US20200197689A1

Movatterモバイル変換

Info

Publication number: US20200197689A1
Application number: US16/809,316
Authority: US
Inventors: Lars Dernebo; Fredrik Lundqvist
Original assignee: Exo Neural Network Inc
Current assignee: Inerventions AB; Exoneural Network AB
Priority date: 2012-06-26
Filing date: 2020-03-04
Publication date: 2020-06-25

Abstract

A garment worn by the patient is provided. The garment has a first sub-control unit electrically connected to a first electrode and a second electrode placed at a first muscle or first nerve of the patient. The first sub-control unit is electrically connected to a master unit. A fifth electrode is provided placed at a head of the patient that measures a brain voltage signal from a brain of the patient. The fifth electrode sends the measured brain voltage signal to a second sub-control unit or the master unit. A sixth electrode is placed adjacent to a heart of the patient that measures a heart signal from the heart of the patient. The second sub-control unit or the master unit analyzing the measured brain voltage signal and/or heart signal to determine which muscle to stimulate. The master unit adapts a first stimulation signal to the first sub-control unit based on the measured brain voltage signal or heart signal. The first sub-control unit stimulates the first muscle or first nerve with the first stimulation signal by sending the first stimulation signal to the first electrode placed at the first muscle or first nerve.

Description

PRIOR APPLICATIONS

FIELD OF THE INVENTION

The present invention relates to a medical therapy arrangement.

BACKGROUND OF THE INVENTION

The present invention relates in general to muscle relaxation, and more particular to muscle relaxation for spastic muscles in patients having injuries to the central nervous system (CNS) at least by using muscle stimulation.

Injuries to the central nervous system (CNS) are difficult to treat and cure. Spastic paresis, which is a pathologically increased muscle tonus caused by an injury to the central nervous system (CNS) is a significant obstacle for prevention of posturing and loss of mobility.

Today, therapeutic alternatives for the reversal of CNS injury symptoms, such as spasticity, are very limited. Therapies are constructed to prevent further loss of function, rather than alleviating the symptoms. No treatment has been found to truly give back function and, in the long run, reversing the injury through muscle relaxation of spastic muscles.

In addition to the spasms themselves, musculoskeletal pain is a common related complaint. Pain originating from dysfunction in the musculoskeletal system is in most cases caused by muscle spasms due to muscular imbalance. If the pain is not treated properly, patients risk developing chronic pain syndromes, conditions that are difficult to cure.

There are several techniques available to affect muscles in the human body. Electrical muscle stimulation (EMS), also known as neuromuscular electrical stimulation or electromyo-stimulation is a commonly known method for increasing muscle mass in specific areas, by providing an electric current into the muscle causing contraction, which gradually leads to increased mass in the treated muscle.

Transcutaneous Electrical Nerve Stimulation (TENS) is closely related to EMS, but instead of stimulating muscles to contract, electric stimulation is used to indirectly treat pain, by distracting the brain through the stimulation of other body parts. In U.S. Pat. No. 4,580,572, a garment for electrical monitoring of sites or electrical stimulation, such as EMS is disclosed.

However, none of the currently known muscle stimulation techniques is suited to provide for targeted muscle relaxation. Hence, a new arrangement including a garment allowing for increased muscle relaxation would be advantageous.

In general, the parameters of the EMS current signal may be chosen which resemble the physiology of the body. The signals in the nervous system may be compared to current impulses (stimuli) to the synapses. When a certain amount of stimuli has occurred, signal substances are excreted.

Generally, a phasic EMS-stimulus is given with a frequency ranging between 2 and 50 Hz, and having a duration between 5 to 300 microseconds.

Muscle relaxation in spastic muscles gives the possibility to induce controlled functional muscle contraction in chosen relaxed muscles. The frequency needed to induce muscle contraction is higher than the frequency used for optimal antagonist muscle relaxation (20 Hz/30 μs). Stimulation frequencies for functional muscle contraction are ranging from 25 to 50 Hz and the duration needed is between 50-300 μs.

The pulsed EMS current signal is controlled by at least the following parameters; pulse frequency, pulse duration, pulse strength.

Experiments have shown that muscles start to contract at a pulse frequency of approximately 15 Hz to approximately 35 Hz, at which frequency range the central nervous system feels the presence of the current signal. The present inventor has realized that by choosing a frequency as low as possible, but still detectable by the central nervous system, the discomfort for the patient is reduced, while the automatic relaxation of the spastic antagonist muscle is taken care of by the central nervous system. A higher frequency than approximately 35 Hz would lead to shortening of the stimulated agonist muscle and therefore activation of the stretch reflex in the antagonist muscle which is not desired, since this would lead to a reciprocal spasm of the agonist muscle.

The pulse duration of the current signal is selected such that it resembles the pulse duration of nervous signals. For example, a pulse duration of approximately 5 to 60 microseconds, such as 30 μs, has been found to be suitable. However, even shorter pulse duration could be advantageous. Too long pulse duration of the EMS current signal does not correspond to the neurophysiologic parameters of the body.

Furthermore, longer pulse duration may also increase the risk of muscle shortage, which is not desired.

Since the spastic muscle behavior in CNS injured patients differs greatly, the professional skills of a neuromuscular system specialist are required for calibrating the system before use, such that the correct agonist muscles are provided with EMS electrodes and joints corresponding thereto are provided with vibrator devices. Every chosen muscle stimulation is paired with an anatomically relevant joint stimulation in order to strengthen the desired relaxation effect. Furthermore, the parameters of the pulsed EMS current signal need to be selected, which parameters may differ between patients.

The above-described stimulation and calibration techniques are further disclosed in WO-2011/067327, which relates to a system and garment for muscle relaxation of a spastic muscle, and is assigned to the applicant of the present application. In particular the system is adapted to cause muscle relaxation by reducing muscular spasticity through stimulation of joints and muscles. The system consists of a garment with electrodes, a hardware unit and software controlling the stimulation.

WO-03/006106 relates to a method and apparatus for electrical stimulation to selected tissues via an array of electrodes positioned on and/or in the body. Each electrode may be connected either as anode, cathode or neither to provide discrimination between stimulated and non-stimulated regions of tissues of the body.

Today, when performing external electrical stimulation therapy, it is common to use electrode patches provided with an adhesive for attaching the electrodes to the patient's skin. These electrode patches are disposable, and it is often very time-consuming to attach the electrodes and to connect the electrical cables to each of the electrode patches.

The object of the present invention is to achieve an improved stimulation therapy arrangement, which is more user-friendly and less time-consuming to use, than the presently used adhesive electrodes.

As an electrical stimulation therapy preferably must be applied at least 30 minutes in order to give prolonged effect, one further and important aspect of the stimulation therapy arrangement is that it is comfortable and easy to use for the wearer.

SUMMARY OF THE INVENTION

One great advantage of the arrangement according to the present invention is that it is easy to use. This is, among other things, related to that the control unit that includes the pulse generating circuitry, is easily attached to the garment by some few manual steps by attaching the connection board to a connection unit which is integrated into the garment.

The garment is elastic and is intended to be tightly worn by the patient. The garment is ready for use in a user-friendly way for external electrical stimulation therapy of muscles. Electrodes, e.g. silicone-electrodes, are arranged at the inner surface of the garment, the surface facing the patient's skin and in contact to the patient's skin. The electrical connections connecting the electrodes to connection units are flexible and elastic.

The garment is made from materials chosen such that the garment may be washed in conventional laundry machines.

In particular the garment includes electrical connections adapted to connect the electrodes to one or several connection units, which do not influence the overall flexibility/elasticity of the garment. This is achieved, according to one embodiment, by integrating, e.g. by weaving silver threads into elastic bands or ribbons or into a piece of elastic.

In another embodiment an insulated conductor is integrated (e.g. weaved) into a piece of elastic.

The connection units are integrated into the garment, they have e.g. a flat extension, and they are flexible. Preferably, they are made from a rubber material and are provided with a magnetic material. In particular each connection element of the connection unit is provided with a magnet beneath the rubber material and arranged such that a connection pad may be attached at the upper surface and held in place by the magnet. The connection pad is naturally also provided with a magnetic material enabling the attachment.

The connection pads are arranged at a flexible flat board having the magnetic material arranged at predefined positions in order to exactly connect each of the connection pads to a mating connection element of the connection unit. The connection board and the connection unit are held together by the magnetic forces created by the magnetic material at the respective parts.

According to one embodiment both the connection unit(s) at the garment and the connection board(s) are made of a flexible material, which is an important aspect making the garment more comfortable to wear.

According to the invention the control unit is adapted to control connection of each of the electrodes to be in the state of acting as anode, cathode, or being disconnected.

By this arrangement it is e.g. possible to stimulate two muscles by three electrodes if the applied stimulation pulses are separated in time, i.e. one of the electrodes are used for both muscles. Thus, the control unit enables a very flexible control of the application of the stimulation pulses and by using short simulation pulse durations very complex stimulation programs may be used in that many muscles and muscle groups may be covered during the therapy.

The control unit preferably applies a so-called open-loop control, i.e. no feedback is used to control the applied current/voltage. The advantage of not using feedback is that in case an electrode temporarily loses contact to the skin, or the contact area between electrode surface and skin decreases, the current density of the remaining contact surface not should incur pain.

The amount of energy supplied to the patient via the electrodes is much lower than the energy levels used for by devices for pain relief. One risk, or drawback, with such devices is that the applied energy might stimulate the muscle to contract.

The level of the stimulation energy used in connection with the present invention is much lower than used for example in the device described in WO-03/006106.

In the present invention, a garment worn by the patient is provided. The garment has a first module electrically connected to a second module. The first module has a first sub-control unit electrically connected to a first electrode and a second electrode placed at a first muscle of the patient and a third electrode and a fourth electrode placed at a second muscle. The sub-control unit is electrically connected to a master unit. The first sub-control unit receives an instruction signal from the master unit. The first sub-control unit distributes stimulation signals to the first, second, third and fourth electrodes based on instructions in the instruction signal. The master unit sends a first stimulation signal to the first sub-control unit. The first sub-control unit stimulates the first muscle with the first stimulation signal without shortening the first muscle by sending the first stimulation signal to the first electrode placed at the first muscle. The stimulation of the first muscle relaxes the second muscle. A measuring unit (U1) of the master unit determines a first current value flowing from the first electrode through the first muscle to the second electrode and sends the first current value to a central processing unit (CPU) in the master unit or the first sub-control unit. The CPU compares the first current value to a current reference value and increases a voltage of the first stimulation signal when the first current value is below the current reference value.

In an alternative embodiment of the present invention, the CPU of the master unit or the first sub-control unit measures a voltage signal between the third electrode and the fourth electrode mounted on the second muscle.

In yet an alternative embodiment of the present invention, the CPU of the master unit sends a data unit with instructions to the first sub-control unit before sending a first stimulation pulse of the first stimulation signal to the first sub-control unit.

In another embodiment of the present invention, the measuring unit U1 determines the first current value by continuously measuring a voltage drop across a resistor R1 prior to a pulse creating switch SW1.

In yet another embodiment of the present invention, the CPU increases a voltage of the first stimulation signal when the first current value is below a start current value.

In an alternative embodiment of the present invention, the switch SW1 is opened when the first current value reaches a stop current value and the switch SW1 is closed when the first current value reaches a start current value that is lower than the stop current value.

In another embodiment of the present invention, a voltage of the stimulation signal is set by allowing the first current value fluctuate between the stop current value and the start current value.

In an alternative embodiment of the present invention, a polarity of the first electrode and the second electrode is switched.

In yet an alternative embodiment of the present invention, the first sub-control unit distributes the first stimulation signal to the first and second electrodes according to the instructions of the data pulse.

In another embodiment of the present invention, the master unit switches the first stimulation signal from being in a voltage mode that has a constant voltage to a current mode that has a substantially constant current wherein the current is only permitted to fluctuate between start current value and the stop current value.

In an alternative embodiment, the CPU changes the frequency and the pulse length of the first stimulation signal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram illustrating the medical therapy arrangement according to the present invention;

FIG. 2 is a schematic cross-sectional view of a part of the connector board and connector unit according to an embodiment of the present invention;

FIG. 3 is a schematic block diagram illustrating another embodiment of the medical therapy arrangement according to the present invention;

FIG. 4 is a schematic front view of the body suit or garment according to the present invention;

FIG. 5 is a schematic top view of a sub-control unit according to the present invention;

FIG. 6 is a cross-sectional side view of the sub-control unit shown inFIG. 5;

FIG. 7 is a schematic view of a stimulation pulse signal at 20 Hz;

FIG. 8 is a schematic view of a stimulation pulse signal at 200 Hz;

FIG. 9 is a schematic view of a sub-control unit connected to an arm according to the present invention;

FIG. 10 is a schematic view of an arrangement that is switchable between a voltage mode and a current mode according to the present invention:

FIGS. 11A-B are schematic views of a current signal when the arrangement shown inFIG. 10 is in the current mode according to the present invention;

FIGS. 11C-D are schematic views of a current signal when the arrangement shown inFIG. 10 is in the voltage mode according to the present invention;

FIG. 12 is a schematic top view of an electrode according to the present invention;

FIG. 13 is a schematic cross-sectional view of an electrode shown inFIG. 12 according to the present invention;

FIG. 14 is a schematic view of a stimulation pulse signal that includes data pulse according to the present invention;

FIG. 15 is a detailed schematic view of a sub-control unit according to the present invention;

FIG. 16 is a detailed schematic view of a sub-control unit connected to electrodes according to the present invention;

FIG. 17 is a schematic view of a distribution unit according to the present invention;

FIG. 18 is a schematic front view of a portion of the body suit shown inFIG. 4 including sub-control unit mounted on the head of the person wearing the body suit according to the present invention;

FIG. 19 is a schematic view of components of the master unit according to the present invention;

FIG. 20 is a schematic view of sub-control unit shown inFIG. 9 connected to movement sensors according to the present invention;

FIG. 21 is a schematic view of an alternative embodiment of the body suit of the present invention;

FIG. 22A is a schematic illustration of a current in a muscle when the arrangement is in the voltage mode;

FIG. 22B is a schematic illustration of a voltage in a muscle when the arrangement is in the voltage mode;

FIG. 22C is a schematic illustration of 100 Ohm electrodes mounted on a muscle with an internal resistance of 6500 Ohm;

FIG. 22D is a schematic illustration of 1000 Ohm electrodes mounted on the muscle shown inFIG. 22C;

FIG. 23 is a schematic illustration of a modified sub-control unit of the present invention;

FIG. 24 is a schematic illustration of a modified portion of the master unit of the present invention;

FIG. 25 is a schematic illustration of an alternative embodiment of body suit the present invention that has large electrodes;

FIG. 26 is a schematic cross-sectional view of an arm module of the present invention;

FIG. 27 is a side view of a standing person wearing the body-suit of the present invention;

FIG. 28 is a side view of a sitting person who is electrically connected to electrodes of the present invention;

FIG. 29 is a front view of a head that has electrodes mounted thereto; and

FIG. 30 is a front view of a head that has electrodes mounted thereto and a schematic view of a master unit and a sub-control unit connected to an arm according to the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention will now be described with references to the appended drawings.

With references toFIG. 1, the present invention relates to amedical therapy arrangement2, for applying electrical stimulation to a human or animal subject, comprising agarment4 adapted to be tightly arranged at said subject, and provided with a plurality ofelectrodes6 at the inner surface which are adapted to be in electrical contact to the skin of the subject.

The arrangement further comprises acontrol unit8 which is adapted to provide eachelectrode6 to work as one or many of anode, cathode or being disconnected, in accordance with a predetermined therapy stimulation program.

At least oneconnection unit10 is provided which comprises a predetermined number ofconnection elements12 being respectively electrically connected to theelectrodes6 viaseparate connection lines14, which are flexible and elastic. And, at least oneconnection board16 is provided which comprises a predetermined number ofconnection pads18 being electrically connected to thecontrol unit8.

Theconnection unit10 is an integrated part of thegarment4 and preferably arranged such that theconnection elements12 are accessible to establish electrical connections to theconnection pads18 of saidconnection board16. In that regard theconnection board16 is detachably attachable to theconnection unit10 by a fastening means20, such that theconnection unit10 and theconnection board16, when attached to each other, are positioned in relation to each other in order to electrically connect theconnection pads18 tomating connection elements12.

According to one embodiment the fastening means20 is adapted to detachably attach theconnection board16 to theconnection unit10 by magnetic forces.FIG. 2 is a schematic cross-sectional view of a part of theconnector board16 and theconnector unit10. In the figure it is shown that the magnetic forces are created by magnetic material, in the figure indicated as separate magnets, arranged at predefined positions of theconnection board16 and theconnection unit10, respectively. In the figure the magnets are arranged behind each of thepads18 andelements12 in order to secure the electrical connection. As an alternative, the magnets may be arranged e.g. behind every second pad and element or at positions close to the pads and elements.

The positions of the magnets at theconnection board16 and at theconnection unit10 ensure that these are correctly positioned in relation to each other. In order to further improve the positioning, one or many protuberances and mating indentations (not shown in the figure) may be arranged at the connection board and connection unit, respectively.

As an alternative the fastening means20 comprises mechanical means which is adapted to detachably attach the connection board to the connection unit. These mechanical means may e.g. comprise one or many Velcro straps arranged to provide for the necessary pressure between the connection board and connection unit in order to establish electrical connection between the pads and elements. The mechanical means may also be embodied by some kind of snap connection.

Preferably, theconnection unit10 has an essentially planar extension and is made from a flexible material, e.g. a flexible rubber material.

Also, in accordance with one embodiment, theconnection board16 has an essentially planar extension and is made from a flexible material, e.g. a flexible rubber material.

However, it is advantageous that, in particular theconnection unit10, is made from a flexible material, in order to make the garment comfortable to wear, but it is also possible, within the scope of the present invention, that theconnection board16 and/or theconnection unit10 is made from a rigid material. According to one embodiment the connection unit is made from a flexible material but the connection board is made from a more rigid material, e.g. from a suitable plastic material.

Theconnection board16 and theconnection unit10 have essentially the same size. In one exemplary embodiment the shape is approximately rectangular having a length in the interval of 8-12 cm, a width of 1.5-3 cm and a thickness of 0.25-1.5 cm.

Naturally, other sizes and shapes are possible, e.g. circular and elliptical, within the scope of the invention as defined by the appended claims.

The connection lines14, that connect eachelectrode6 to arespective connection element12, are flexible and elastic such the wearer of the garment may move unimpededly.

According to one embodiment theconnection line14 is included into a piece of elastic into which an electrical conductor is integrated. This is achieved e.g. by weaving conducting threads, e.g. made from silver, into the piece of elastic.

As an alternative theconnection line14 is an insulated conductor being directly integrated, e.g. by weaving, into the material of the garment.

Thecontrol unit8 is preferably a separate unit in relation to theconnection board16, and that theconnection pads18 are connected to thecontrol unit8 via anelectrical cable22. According to one embodiment thecontrol unit8 comprises a stimulation pulse generator, an energy source, a storage means, an input/output unit and a coupling unit. The energy source, typically being a battery, e.g. a rechargeable battery, is adapted to energize the circuitry of the control unit, e.g. the stimulation pulse generator. The predetermined therapy stimulation program is stored in the storage means and specific instructions related to the specific patient to be treated is input by the physician via the interface. The input/output unit may include one or many buttons and a display, e.g. a touchscreen.

The control unit is preferably attached to the garment wearer by some kind of strap in a position where it is easily accessed but not prevents movements.

In accordance with another embodiment the control unit instead is an integral part of the connection board, and then the connecting electrical cable is obviated.

The control unit is preferably adapted to apply an open-loop control when controlling the application of stimulation pulses. I.e. no feed-back is used which is advantageous in order to avoid that higher stimulation current is applied in the situation where an electrode loses, or has less, contact to the skin.

The garment is preferably made from a predetermined number of interconnectable parts. The reason is that the garment then is easier to put on. Each part is then provided with a connection unit that in turn is connected to the electrodes.

For some patients only a part of the body has to be subjected to stimulation, e.g. an arm or a leg. In that case a garment is used that is adapted to enclose that part. And, for other patients, the entire body has to be enclosed by the garment in order to gain full effect of the therapy.

An overall requirement of the garment is that it may be tightly arranged at the body to secure that the electrodes are in contact to the skin of the patient. The garment must be able to be washed in a normal laundry machine. Preferably the garment comprises a synthetic fiber made from a polyurethane-polyurea copolymer, e.g. spandex or elastane.

According to an embodiment, the garment comprises five major textile and support materials. Elastic spandex for areas covering muscles and, embedded in this spandex, muscle electrodes for skin contact; firm elastic spandex textile in joint areas to induce joint stability and specific skin contact of embedded muscle and vibration (if included) electrodes; and Velcro to interlock the garment parts and also induce joint stability and electrode skin contact. Zippers are placed in the different garment parts to enable simple dressing and use of the garment. Padding and other supportive materials are placed between the textile layers to enhance stability and electrode skin contact.

In order to provide for a perfect garment fit for each patient, each garment may be tailor made for each patient. Hence, each patient may be individually measured. Based on the calibration made by the specialist, the therapist chooses which muscles to stimulate and therefore induce muscle relaxation of corresponding spastic muscles. The tailor-made garment is produced and the control unit is programmed with the necessary parameters such as to perform a vibrator (if included) and EMS stimulation in the prescribed manner.

The electrodes are arranged at the inner surface of the garment and must therefore be flexible to adapt to the skin surface. According to one embodiment the electrodes are, for example, silicone-electrodes or any other conductive electrode materials. The number of electrodes is naturally dependent upon the therapy to be applied, but preferably at least ten electrodes are included, often much more.

According to another embodiment the control unit comprises a sensing unit adapted to receive electrical signals, e.g. EMG-signals, sensed by one or many of said electrodes. The received signals may then be analyzed and used to improve the therapy. According to one aspect the sensed electrical signals are used to decide which therapy to be used and then apply that therapy in accordance with an open-loop controlled stimulation therapy. According to another aspect, it would also be possible to apply the arrangement in a closed-loop controlled simulation therapy where the applied stimulation energy is adapted in dependence of sensed electrical signals.

In a further embodiment the arrangement also provides for combined electrical and vibration therapy. This embodiment is schematically illustrated inFIG. 3. The same references used inFIGS. 1 and 2 apply here as well. To use a combined electrical and vibration therapy has proven an advantageous therapy and in accordance to this embodiment a plurality ofvibration units7 are arranged at the garment, e.g. at the inner surface of the garment, and wherein each vibration unit being connected to the connection unit via a flexible and elastic vibrationunit connection line15. The vibration units may also be arranged at the outer surface of the garment and apply the vibrations through the garment material.

Different types of vibration units may be used, e.g. based upon piezo-technology, a so-called DC-motor, or a solenoid-based unit.

Preferably the relation between the number of electrical stimulation electrodes and vibration units is 2:1. However, even fewer vibration units may be used.

FIG. 4 is a schematic view of a frontside of a garment of an elastic andtight body suit100 of the present invention. Thebody suit100 has a backside that is substantially similar to the frontside. The backside of the body suit could be designed with wires, electrodes, sub-control units in a way that is identical or similar to the frontside. Thebody suit100 has a plurality of sub-control units integrated into the fabric that are electrically connected to a plurality of electrodes that are located on an inside of the fabric so that the electrodes are facing and urged towards the skin of the person wearing thebody suit100. The sub-control units make it possible to substantially increase the number of electrodes in thebody suit100 and to carry out more advanced treatments of the patient wearing the body suit.

An important feature of the present invention is that the electrodes not only activate the muscles but also the afferent (sensory) nerves in the muscles that conduct sensory signals from muscle and skin sensors to the spinal cord and act as input to the interneuron networks that are responsible for controlling the movement of body parts such as an arm or a leg. This happens when the afferent nerves are stimulated at about 20 Hz and at a low enough voltage so that the agonist muscle does not contract to cause movement. Upon receipt of the sensory signals from the afferent nerves, the spinal cord sends a signal to the agonist muscle to relax the muscle. It is important that the frequency range of the stimulation signal can be changed to optimize the afferent input to the interneuron networks. It is to be understood that any reference to the stimulation of muscles includes the stimulation of nerves in the muscles and other nerves adjacent to the electrodes.

Thebody suit100 is used to stimulate and relax muscles and nerves, of the person wearing the body suit, with electrical pulse current flowing between electrodes mounted in the fabric of thebody suit100 and through the muscles on which the electrodes are positioned. When the body suit has a large number of electrodes but no sub-control units, this creates a problem because all the electrodes must be connected to the controller or master unit that transmits the pulses and current and other information via wires to the electrodes. The large number of wires required integrated in the suit makes the body suit prone to faulty connections over time as the body suit is worn by the person and is taken on and off. One solution to this problem is to use sub-control units to reduce the number of wires in the body suit and the required lengths of the wires going to the electrodes i.e. the wire lengths are also reduced. The body suit can include modules wherein the sub-control units in each module are distributing the stimulation pulses that arrive from the master unit.

The sub-control units are controlled by the master unit. Preferably, but not necessarily, each sub-control unit is electrically connected to the master unit via only a few wires such as two wires that provide the power voltage and pulse signals going to the sub-control units. The pair of wires can also carry data instructions to the sub-control units. It is also possible to send the data instructions by wireless communication between the master unit and the sub-control units.

As described in detail below, one important advantage of using the sub-control units is that a higher frequency and more electrodes can be used in the body suit. In general, the sub-control units receive pulsating stimulation signals from a programmable master control unit that the sub-control units distribute to pre-determined electrodes to stimulate and/or relax muscles and muscle pairs located below the electrodes. It is also possible to stimulate nerves similar to stimulating muscles. Muscles are merely used as an illustrative example but the stimulation also applies to nerves in the same way. The master control unit is detachably and electrically connected to the body suit at connectors that are located on an outside of thebody suit100. The master control unit also has a power source to power the sub-control units located in the modules of the body suit. The modules are electrically connected to one another via connectors that are electrically connected to the sub-control units. An important feature is that the master control unit may be detached from a first connector on the body suit and re-connected to a second connector on the same body suit so that the master control unit or master unit can be moved between various connectors of the body suit. Each connector has a positive and negative pole on a first side and a corresponding positive and negative pole on the second opposite side of the connector. The positive pole on the first side is electrically connected to the positive pole on the second side and the negative pole on the first side is electrically connected to the negative pole on the second side so that each connector acts as a “bridge” to carry power, data and pulses from one module to the adjacent module. A stimulation program runs in the master control unit, that includes instructions that are sent to the sub-control units through a serial data bus.

The garment orbody suit100 is preferably made of a flexible and elastic fabric material that tightly fits the body of the patient to be treated. It is to be understood that thebody suit100 is schematically shown to illustrate the principles of the present invention and that the exact location of the various components can change or be customized to the specific needs of the patient to be treated. If thebody suit100 should include a large number of electrodes without the use of sub-control units, this would require large numbers of wires that extend from the master unit to all the electrodes. The large number of wires required sometimes makes it unpractical to fit them all in the fabric of the body suit and the frequency range must be reduced to low frequencies, as explained in detail below. An important feature of the present invention is the idea of moving some of the intelligence to the sub-control units that are located in the body suit modules in order to reduce the required wiring and improve the functionality of thebody suit100 and to allow higher stimulation frequencies.

More particularly, thebody suit100 may include detachably and independently functioning modules such as aright arm module102, anupper body module104, aleft arm module106, apelvis module108, aright leg module110 and aleft leg module112. The modules are preferably attached to one another by a

suitable fastening mechanism

114,116,118,120 such as zippers, Velcro or any other suitable mechanism that can easily be attached and detached. One advantage of using modules is that the patient may need different sizes on different parts of the body. In some instances, the patient may not need all the modules because certain parts of the body are healthy and do not need to be treated. In general, the paralyzed body portions are smaller in size than the non-paralyzed body portions so that different sizes may be needed. Similarly, a body part, such as an arm, that is spastic is generally smaller than a non-spastic body part. The number of electrodes and sub-control units in each module may vary and thebody suit100 should merely be treated as an illustrative example.

Theright arm module102 has a firstsub-control unit122 electrically connected via a flexible andelastic wire124 to anegative pole126 of afirst connector128 and via a flexible andelastic wire130 to apositive pole132 of thefirst connector128. One important function offirst connector128 is to provide a “bridge” from theright arm module102 to theupper body module104 so that they are electrically connected. This function applies to all the other connectors of thebody suit100. The connectors may be made of a flexible fabric that includes conductive wires to electrically connect the positive pole on one module with the positive pole on the adjacent module and to electrically connect the negative pole on one module with the negative pole on the adjacent module. Thesub-control unit122 is electrically connected to

electrodes

134,136,138,140,142,144,146 and148 via flexible and

elastic wires

134a,136a,138a,140a,142a,144a,146aand148a, respectively. Theright arm module102 is electrically connected to all the other modules of thebody suit100 via the connectors that extend between the modules and connect one module to an adjacent module.

The upperfront body module104, preferably, has two sub-control units i.e. a secondsub-control unit150 and a thirdsub-control unit152. Themodule104 may have more or fewer sub-control units and the use of two modules is merely an illustrative example. Thesub-control unit150 is electrically connected via a flexible andelastic wire154 to a flexible andelastic wire155 that is connected to apositive pole156 of thefirst connector128 and via a flexible andelastic wire160 to a flexible andelastic wire157 that is electrically connected to anegative pole162 of thefirst connector128. Thewire155 is also electrically connected to apositive pole194 of aconnector196 that is connected to theleft arm module106 and thewire157 is electrically connected to anegative pole200 of theconnector196. A flexible andelastic wire175 is electrically connected to wire155 and leads to the backside of thebody suit100 that is identical or similar to the front side shown inFIG. 4. Another flexible andelastic wire177 is electrically connected to wire157 and extends to the backside of thebody suit100 so that the

wires

175,177 provide the power, pulses and possibly data to the backside of the body suit in the same way as to the front side of the body suit. Thesub-control unit150 is electrically connected to

electrodes

164,166,168,170,172,174,176 and178 via flexible and

elastic wires

164a,166a,168a,170a,172a,174a,176aand178a, respectively. Thebody module104 is electrically connected to all the other modules of thebody suit100 via the connectors that extend between the modules and connect one module to an adjacent module.

Similar tosub-control unit150,sub-control unit152 is electrically connected via a flexible andelastic wire192 to wire155 that is electrically connected to thepositive pole194 of asecond connector196 and via a flexible andelastic wire198 to wire157 that is electrically connected to thenegative pole200 of thethird connector196. Thesub-control unit152 is electrically connected to

electrodes

202,204,206,208,210,212,214 and216 via flexible and

elastic wires

202a,204a,206a,208a,210a,212a,214aand216a, respectively.

Similar to theright arm module102, theleft arm module106 has a fourthsub-control unit228 electrically connected via a flexible andelastic wire230 to apositive pole232 of thesecond connector196 and via a flexible andelastic wire234 to anegative pole236 of thethird connector196. Thesub-control unit228 is electrically connected to

electrodes

238,240,242,244,246,248,250 and252 via flexible and

elastic wires

238a,240a,242a,244a,246a,248a,250aand252a, respectively.

Thepelvis module108 is located below theupper body module104 but above the

leg modules

110,112. Thepelvis module108 is shown without sub-control units but themodule108 may also be provided with sub-control units similar to the other modules. Themodule108 has anupper connector184 that electrically connects thepelvis module108 to theupper body module104. Theupper connector184 has apositive pole268 and anegative pole272 on thepelvis module108 and apositive pole182 and anegative pole188 at the bottom end of thebody module104. Thepositive pole268 is electrically connected to thepositive pole182 and thenegative pole272 is electrically connected to thenegative pole188. Thepositive pole182 is electrically connected to wire155 via flexible andelastic wire159 and thenegative pole188 is electrically connected to wire157 via flexible andelastic wire161. Thepositive pole268 is electrically connected to thepositive pole276 of athird connector278 via a flexible andelastic wire163. Thenegative pole272 is electrically connected to thenegative pole282 ofconnector278 via a flexible andelastic wire165. Thepositive pole268 is also electrically connected to thepositive pole262 of afifth connector286 via a flexible andelastic wire167. Thenegative pole272 is electrically connected to thenegative pole264 of thefifth connector286 via a flexible andelastic wire169. All the

connectors

128,184,196,278 and286 include elastic wiring to electrically connect one module with another module.

Theright leg module110 has a fifthsub-control unit294 electrically connected via flexible andelastic wire296 to apositive pole298 of thefourth connector278 and via a flexible andelastic wire300 to anegative pole302 of thefourth connector278. Thepositive pole298 is electrically connected to thepositive pole276 and thenegative pole302 is electrically connected to thenegative pole282. Thesub-control unit294 is electrically connected to

electrodes

304,306,308,310,312,314,316 and318 via flexible and

elastic wires

304a,306a,308a,310a,312a,314a,316aand318a, respectively.

Theleft leg module112 has a sixthsub-control unit320 electrically connected via a flexible andelastic wire322 to apositive pole324 of thefifth connector286 and via a flexible andelastic wire326 to anegative pole328 of thefifth connector286. Thesub-control unit320 is electrically connected to

electrodes

330,332,334,336,338,340,342 and344 via flexible and

elastic wires

330a,332a,334a,336a,338a,340a,342aand344a, respectively.

Themaster unit266 is connectable to the body suit in many places.FIG. 4 shows thepositive pole264 of themaster unit266 electrically connected to thewire155 via flexible andelastic wire171 and thenegative pole262 electrically connected to wire157 via flexible andelastic wire173. If one of the modules is not necessary such as theright arm module102, it is possible to connect themaster unit266 to thefirst connector128 or to any of the other connectors. It is an important feature to be able to connect the master unit at a place that is convenient to the patient in case the patient has a handicap that makes it, for example, difficult to attach the master unit at the hip or if it is more convenient to attach the master unit at the upper shoulder when the patient is in a sleeping position. It is also possible to place several connectors in different places in the bodysuit so that the master unit can be placed there. Preferably, the master unit should be attached to any of the available connectors on thebody suit100. It is thus not necessary to have a separate connection that is only located in one place such as by the hip. It is thus possible to have several different connection points or connectors for the master unit.

FIG. 5 is a schematic detailed top-view ofsub-control unit122. Preferably, all the sub-control units in the garment orbody suit100 are substantially similar tounit122 serves as an illustrative example that applies to all the sub-control units. Preferably, theunit122 is molded in a water-resistant material to make it water resistant so that the body suit can be machine washed without damaging the electronics in the unit. Theunit122 may have eight extensions wires that extend outwardly from the molding i.e.

extensions

134b,136b,138b,140b,142b,144b,146band148bthat are electrically connected to134a,136a,138a,140a,142a,144a,146aand148a(best shown inFIG. 4), respectively. This corresponds to 4 pairs of electrodes per sub-control unit. Theunit122 may have more or fewer extensions than eight.Sub-control unit122 also has

extensions

124band130bthat are electrically connected to the

wires

128 and130, respectively, that extend to the connector128 (best shown inFIG. 4). Power, data and stimulation pulses may enter thesub-control unit122 via

extensions

124b,130bfrom themaster unit266. It is also possible to have more connections and send additional information in addition to the power, data and pulse information shown inFIG. 5. Any suitable serial communication technology may also be used and more than two wires/connectors can be used that are serially connected. It is to be understood that it is possible to combine electrodes in different ways to obtain more than four combinations.

When a frequency of 200 Hz is used for the stimulation signals/pulses, there is a total time period of 5 milliseconds available to send out all the combinations that the sub-control units handle. If, for example, 8 combinations are used then there are 5 milliseconds divided by 8 i.e. 625 microseconds between the start of each pulse. If the pulse length is 175 microseconds then there are 625 microseconds minus 175 microseconds=450 microseconds time gap between the pulses i.e. when there is no pulse signal before the next pulse starts. In other words, if, for example, 8 combinations are obtained and the pulse length is 175 microseconds and the frequency is 200 Hz then the time gap between the pulses is 450 microseconds. The time gap can be used to do other things such as measuring feedback signals from an antagonistic muscle, as described in detail below in connection withFIG. 9 or to send data as described inFIGS. 14 and 16. It is to be understood that the frequencies can be increased to a frequency higher than 200 Hz as long as there is a time gap between each pulse.

FIG. 6 is a schematic detailed side view ofsub-control unit122 that is connected to

flexible wires

138a,146avia sewable flexible conductive connections or

extensions

138b,146bthat come out from the molded sub-control unit, respectively, by overlapping the wires from the garment to the connectors from the sub-control and then sew them together so that they are electrically connected. This principle or another connection method may be used on all the wires and extensions on all the sub-control units.

As a safety precaution, it is preferred that only the master unit sends out the stimulation pulses via the sub-control units to prevent the sub-control units from sending out unintended pulses that could be very uncomfortable or even dangerous to the patient wearing thebody suit100. The sub-control units thus merely direct or distribute the pulses to the correct pair of electrodes. The stimulation pulse, pulse length (duty cycle) and voltage/current etc. are controlled by the (central processing unit) CPU of the master unit by serial data communication with all the sub-control units before the pulses are sent out from the master unit.

As described in more detail below, the sub-control units may have information about the desired pulse length so that the correct pulse length is sent out to the electrodes. The longer the pulse length the more powerful the stimulation is. The pulse length may be set by the therapist of the body suit or be set by the master unit. In general, the pulses from the master unit have a pulse length that is slightly longer than the longest pulse length of the stimulation pulse distributed by the sub-control units. When the pulse length from the master unit is longer than the predetermined pulse out time period then the sub-control unit can control or reduce the length off the pulse to the electrodes. The master unit also has a safety mechanism for turning off any pulse that is longer than a predetermined time period as programmed in the master unit. In the preferred embodiment, these safety mechanisms are not controlled by the CPU but by circuits in the hardware that are separate from the CPU and the software for higher safety.

More particularly and as indicated above, two of the

connectors

After a certain number of stimulation pulses have been sent to the sub-control unit, it may be necessary to send different or the same instructions to the sub-control unit before additional pulses are sent from the master unit to make sure the sub-control units are properly synchronized and to ensure that the pulses are sent to the correct electrodes. This synchronization may be done by sending short synchronized instructions via the serial data-bus. In some instances, it may be necessary to turn off the data flow to the sub-control unit before the stimulation pulse is sent. It should be understood that the stimulation pulses and data are not transmitted simultaneously when a two-wired bus is used. The sub-control unit may require to be powered at 3V3 volt (3.3V) or 5V. Other voltage levels may be used but the lower the voltage of the power the more sensitive the system becomes to interferences.

The sub-control units may be designed so that they do not permit a stimulation pulse that is longer than a certain threshold value such as 200 microseconds or any other suitable pulse length to pass through to the electrodes. Similarly, the master unit may also be designed so that it cannot send out stimulation pulses that are longer than another threshold value such as 250 microseconds. If the processor of themaster control unit266 tries to send out a stimulation pulse that is longer than the threshold value then the safety circuit of the hardware terminates the stimulation pulse as a safety precaution. The threshold values can be adjusted so that longer and shorter duty cycles can be used.

Preferably, the stimulation pulse from themaster control unit266 to thesub-control unit122 should be slightly longer (such as a few microseconds and up to 30 microseconds) than the maximum pulse length that is distributed from the sub-control unit to the electrodes so that there is time for the voltage to be received by the CPU of the sub-control unit and to the output circuit to power up the pulse in the output circuit on the sub-control unit before the stimulation pulse is distributed to the electrodes. The sub-control units may be designed to delay sending the stimulation pulses to the electrodes with, for example, 10 microseconds to ensure there is sufficient time for the circuitry on the sub-control units to handle the incoming stimulation pulses from the master unit. It may also be possible to connect the sub-control units to the master unit via blue-tooth, wi-fi, one-wire data bus or any other suitable wireless or on wire data technology in order to send data to and from the sub-control units to the master unit.

FIG. 7 is aschematic view200 of thestimulation pulses202 that are sent to electrodes in the garment. More particularly,FIG. 7 illustrates an example of when 40 stimulation pulses are sent at 20 Hz and the pulse period is 50 milliseconds long in a system that handles all 40 electrodes from one unit. As explained in detail below, when a frequency of 200 Hz is used it is not possible to fit in 40 stimulation pulses (with a duty cycle of 175 microseconds) during the pulse period of 5 milliseconds. By using sub-control units, it is possible to increase the frequency because there are fewer stimulation pulses per sub-control unit, as shown inFIG. 8. At a frequency of 20 Hz, the time period for one cycle is 50 milliseconds (or 0.05 seconds).FIG. 7 shows 40 pulses or stimulation combinations wherein each pulse has a duty cycle (pulse length) of about 175 microseconds. Each stimulation pulse activates a pair of electrodes. It should be understood that the duty cycle can be shorter or longer than 175 microseconds. After 50 mS at 20 Hz a new frequency cycle is started. The treatment of a patient wearing thebody suit100 may typically last for an hour or so but shorter and longer treatment periods may also be used. Frequency of 20 Hz is suitable to stimulate an agonist muscle in order to relax an antagonist muscle but higher and lower frequencies of the pulse signal may also be used. An important advantage is that after the treatment has stopped, the antagonist muscle remains relaxed for many hours and in some cases for days.

It is desirable to have the ability to change the frequency range so that the frequency used can be customized to the required treatment of the patient. Preferably, it should be possible to change the frequency range between 1 Hz-200 Hz. It should also be possible to vary the voltage used i.e. to change the amplitude of the pulses. One problem is that if 40 stimulation pulses are desired at 200 Hz, only a time period of 5 mS is available (when one frequency cycle at 200 Hz) and if the pulse length is 175 microseconds then the total pulse length for 40 pulses is 7 mS (40×175 microseconds) without the time gap between pulses which exceeds the time period available (5 mS) for one frequency cycle so it is not possible to run the system at 200 Hz.

FIG. 8 is a schematic view of astimulation signal512 withstimulation pulses494 at a 200 Hz frequency at onefrequency cycle496 of 5 mS so that there is atime gap498 between eachstimulation pulse494. Higher or lower frequencies ofstimulation signal512 may also be used and 200 Hz is merely an illustrative example. Eachstimulation pulse494 has a pulse length orduty cycle495. This means there is enough time to send out about 20 stimulation pulses as a maximum of combinations when the frequency is 200 Hz and the pulse length orduty cycle495 is 175 microseconds for each pulse. It is necessary to have a time gap between the outgoing pulses. If 5 milliseconds are divided into 20 pulses, 250 microseconds are available for each stimulation pulse and if the pulse length is 175 microseconds then there is a time gap of 75 microseconds between each stimulation pulse. As indicated above, this can be solved by using sub-control units in each module, as shown inFIG. 4. When sub-control units are used in the body suit each sub-control unit may, for example, be connected to 8 electrodes. This means that a higher frequency than 20 Hz may be used and that it is possible to carry out more than 8 stimulation combinations per sub-control unit. In other words, it is not necessary to limit the use to certain pre-set pairs of electrodes but use different combinations of electrodes that are stimulated. For example, it may be possible to send stimulating pulses to electrodes that are located on the same side of an arm but at a distance from one another. It is also possible to send stimulating pulses to electrodes that are located on opposite sides of the arm such as one electrode at the front of the arm and another electrode located at the backside of the arm. It is also possible to combine the sub-control units so that, for example, a sub-control unit (such as unit150) in the upper body module distributes a stimulation pulse to a positive electrode (such as electrode174) in that module while another sub-control unit (such as unit152) in the upper body module negatively activates an electrode (such as electrode204) in the upper body module so that are current goes from the positive electrode of one sub-control unit to the negative electrode of another sub-control unit

When, for example, four electrodes are used, it is possible to stimulate the electrodes in more than two ways when each pulse corresponds to or activates a pair of electrodes. By using sub-control units, the available time period available (5 ms) at 200 Hz is enough time to stimulate 8 electrodes because when the duty cycle for each pulse is 175 microseconds. It is possible to generate at least 25 different pulses to electrodes or fewer during this time period which is more than sufficient to stimulate different combinations of 4 pairs of electrodes. In practice, fewer than 25 pulses can be generated because it is important to have a time gap between each pulse in case, for example, there may be a need to take measurements on the antagonist muscles between the pulses or to communicate with the master unit during the time gap between the stimulation pulses. It is undesirable to take measurements during the duty cycle of a stimulation pulse because the stimulation pulse to a certain muscle and/or nerve (agonist) is likely going to interfere with the measurements of the voltage signals at another adjacent muscle (antagonist).

FIG. 9 is an illustrative example of a patient'sarm509 inside theright arm module102 ofbody suit100. The arm is shown in an extended semi-straight position although it is most common for spastic patients that the arm is locked in a bent position and the patient finds it difficult or impossible to stretch out or extend the arm without assistance. Theelectrode134 may be placed at insertion orfirst end500 of an agonist muscle and/ornerve502 whileelectrode136 may be placed at origin or secondopposite end504 of the muscle and/ornerve502 so that current passes from thesub-control unit122 viastimulation signal512 to theelectrode134 via and through the agonist muscle and/ornerve502 to theelectrode136 and then back viareturn signal515 to thesub-control unit122. The direction of the current flow may be changed so that the current flow goes in the opposite direction, as described in detail below regardingFIG. 15. Theelectrode138 may be placed at insertion orfirst end506 of anantagonist muscle508 and theelectrode140 may be placed at origin orsecond end510 of theantagonist muscle508. It is also possible to place the electrodes in the middle of or at another place of the muscle or nerve. It is also possible to use separate electrodes to measure signals from the muscle and other signals such as EMG signals.

For example, the agonist muscle and/ornerve502 may have a function of moving thearm509 in a first direction while the antagonist muscle and/ornerve508 has the function of moving the arm in a second direction that is opposite the first direction. Agonist/antagonist pairs of muscles are needed in the body because muscles can only exert a pulling force and cannot push themselves back into their original position. For example, the upper arm has biceps and triceps muscles. When the biceps muscles are contracting, the triceps muscles are, in a normally functioning person, relaxed and stretched back to their original position. The opposite occurs when the triceps muscles contract. The muscle that contracts may be labeled the agonist muscle while the muscle that is relaxed/stretched may be labeled the antagonist muscle.

An important insight of the present invention is that a mild stimulation of the agonist muscle leads to slight contraction (increased tension) without shortening of the agonist muscle and a relaxation of the antagonist muscle through reciprocal inhibition. When the antagonist muscle is spastic, the muscle is abnormally tense. The agonist muscle should be stimulated without the agonist muscle causing a movement of, for example, the arm. If the agonist muscle is stimulated too much, a movement of the arm is created and the antagonist muscle may respond by becoming tense again which is undesirable. Too much stimulation of the agonist muscle may be caused by using a frequency that is too high, a pulse that is too long or a current/voltage of the stimulation signal that is too high. When the agonist muscle is merely stimulated to generate a signal to the central nervous system without causing the agonist muscle to shorten, the reciprocal inhibition causes the antagonist muscle to relax so that it is in a reduced spastic state. The relaxation of the spastic muscle can sometimes also remove pain in the spastic muscle particularly for patients who do not have a brain damage. The stimulation may also be used to treat pain, tremors, muscle regeneration, induce muscle elaxation, reduce spactisicty, reduce pain, increase muscle tone, facilitate muscle contraction, induce muscle contraction, increase muscle strength/mass, accelerate regeneration of muscles/nerves, increase blood flow/circulaton, increase blood oxygeneation, reduce vein tension, induce relaxation, improve sleep, reduce tremours, reduce bed soars (abitus redution), reduce pathological reflexes/central nerve reflexes, treat depession, reduce trauma, use as tensin reduction therapy, induce embodyment practice, hyperactivity disorders, autism spectrum deseases and reduce stress disorders.

It is also possible to measure the brain voltage signals (such as electroencephalogram (EEG) signals) (seeFIG. 18 for details) or activity of the person wearing thebody suit100 during treatment so that it is recorded what the brain voltage signals are when the person thinks about moving the arm. This activity can be stored in the master unit so next time the patient thinks that he/she would like to move the arm, the system of the present invention recognizes the brain activity by comparing the measured signals with the recorded signals and artificially provides the correct stimulation signals to the muscle to actively move, for example, the arm in the way the patient wanted according to the brain signals of the person. There may be another different brain signal activity when the patient wants to do something else such opening a hand that the system could also recognize and then (after the antagonist muscle has first been relaxed) sends the appropriate stimulation signal to the correct agonist muscle to open the hand. The master unit may first receive the brain signals and then convert this information to the correct stimulation signals to the various muscles. As best shown inFIG. 9, themaster unit266 sends out thepulsating stimulation signal512 viasub-control unit122 to the

electrode pair

134,136 to sufficiently stimulate theagonist muscle502 to cause a natural signal (triggered by muscle508) to be sent from themuscle508 to the central nervous system without causing themuscle502 to shorten.

Thesignal512 includes pulses494 (as shown inFIG. 8) at a desired pulse frequency such as any value between 1-200 Hz and with short pulse lengths (duty cycle) so that there aretime gaps498 between thepulses494. By using a sensitive measuring device, it is possible to measure a voltage difference between

electrodes

138 and140 placed on theantagonist muscle508 or separate sensors. In this way, the voltage signal fromelectrode138 is compared to the voltage signal fromelectrode140. Preferably, this voltage should be measured during thetime gap498 so that thestimulation pulse494 does not interfere with the measurement. The measured voltage is indicated in a feed-

back signal

547 or549 signal from theantagonist muscle508. The feed-back signals are preferably amplified by an amplifier. More particularly, the measuring device should be able to measure micro to milli-volts differences between two electrodes that are mounted on theantagonist muscle508 that is not used for the stimulation. It is important to realize that just because the natural voltage signals from the muscles are so small, it is necessary that the sub-control unit is close to (no more than a couple of decimeters) the electrodes. Otherwise, if the measurement device is far away such at the hip the millivolt signals from the arm muscle disappear into the white noise and/or are interfered with by other electrical signals in the bodysuit. It is also possible to use separate or different electrodes for these measurements. It is thus important that this feedback voltage signal is only measured during thetime gap498 between thepulses494 so that the stimulation pulses sent to theagonist muscle502 are not interfering with the delicate measurements at theantagonist muscle508. It is also possible to simultaneously treat many parts of the body so that signals are simultaneously activated from several sub-control units. Of course, it is also possible to stop sending the stimulation pulses during the measurement of the antagonist muscle when the time to measure between the pulses is too short. The feedback voltage signal between 547 and 549 decreases as theantagonist muscle508 becomes more relaxed as an indirect result of the mild stimulation of theagonist muscle502. The feedback voltage signal can be compared to earlier measured values so that it is possible to see how theantagonist muscle508 becomes more or less relaxed. For example, if the voltage value is first measured to, for example, 2 mV and when the voltage value is gradually reduced to, for example, 1 mV, this means the stimulation effect of theagonist muscle502 has had a desired effect on theantagonist muscle508. It is to be understood that it is the naturally occurring voltage caused by the central nervous system in theantagonist muscle508 that is measured before, during and after treatment of theagonist muscle502.

The naturally occurring voltage in theantagonist muscle508 is very small and requires an amplifier to be detected and measured. In the preferred embodiment, thesub-control unit122 has afirst amplifier123 and aswitch control125 that can be switched between an open or closed position.FIG. 9 shows theswitch control125 in an open position which is the position used when thepulse494 ofstimulation signal512 is being transmitted to themuscle502 to stimulate it. When theswitch control125 is in a closed position, the voltage between

electrodes

134,136 may be measured via

lines

512,515, when in between the pulses or when the switch is closed and thestimulation signal512 is stopped. This means the

electrodes

134,136 may be used not only to stimulate themuscle502 but also to measure the natural voltage in the muscle after it has been exposed to thestimulation pulses494. It should be understood that

muscles

502,508 are merely illustrative examples and that all the muscles associated with the sub-control units can be stimulated and measured in the same way. Thesub-control unit122 also has asecond amplifier127 and aswitch control129 that can be switched between an open and closed position. InFIG. 9, theswitch control129 is shown in a closed position which means that the voltage between the

electrodes

138 and140 may be continually measured

lines

547,549 or only measured during thetime gap498 betweenpulses494 ofsignal512 sent tomuscle502 in case thepulses494 interferes with the measurement of the voltage inmuscle508. In this way, it can be determined how the naturally occurring voltage (caused by signals from the central nervous system) between

electrodes

138,140 placed onmuscle508 changes as a result of the pulse stimulation ofmuscle502. In general, as themuscle508 becomes more relaxed the naturally occurring voltage between the

electrodes

138 and140 decreases. As indicated above, it is important to only measure the voltage between

electrodes

138,140 during thetime gap498 of thestimulation pulses494 ofsignal512 tomuscle502 because if the measurement is done during the duty cycle of one of thepulses494 then there is a risk that the pulse would interfere with or distort the voltage measurement between

electrodes

138,140 mounted onmuscle508. It is also possible to measure the voltage between

electrodes

134,136 mounted onmuscle502 during thetime gap498 whilemuscle502 is being treated with thestimulation pulses494. This can be done by switching theswitch control125 to the closed position during thetime gap498 and then switch it to the open position before thenext pulse494 is sent tomuscle502. In this way, the changes of the naturally voltage of themuscle502 that is being stimulated can also be measured. It is also possible to stop the pulsating stimulation signal while the measurements take place. It is to be understood that the measurements described above apply to all the electrodes connected to the sub-control units and combinations of stimulations via the electrodes connected to the sub-control units.

Instead of using a separate device to measure the feedback signal in theantagonist muscle508 which means the stimulation signals512 of theagonist muscle502 must be stopped during the measurement, it is desirable to make it possible to measure theantagonist muscle508 during the treatment of theagonist muscle502 i.e. continuously or during thetime gaps498 between the stimulation signals512 that are sent to theagonist muscle502. The measurement of themuscle508 may result in that the stimulation of themuscle502 should be changed to a different program or the parameters should be modified such as changing the voltage, current, frequency or pulse length of thestimulation signal512. The stimulation ofmuscle502 is thus artificially created by sending thestimulation pulses494 insignal512 to theelectrode134 while it is the naturally occurring voltage of the antagonist muscle508 (reciprocal inhibition) that is measured and how the current changes inmuscle508 as a result of the artificial stimulation ofagonist muscle502. It is desirable to also save the frequency, amplitude of the current/voltage of thestimulation signal512 that stimulatedagonist muscle502 so that the same parameters can be used the next time themuscle502 needs to be stimulated. As explained in detail below, it may be necessary to calibrate thesignal512 if it is a voltage mode pulse because the natural resistance of the muscle or the contact of the electrodes with the skin changes over time due to, for example, different humidity or the skin of the patient contains more moisture compared to the prior measurement or changes in the connections between the electrodes and the skin of the person wearing the bodysuit. However, if it is a current controlled pulse it can be regulated to a fixed current (current mode). For example, it may be necessary to increase the voltage of thesignal512 to provide the same amount of current running throughmuscle502, as described in detail inFIG. 10. This information may be saved in themaster unit266 that is connected to thebody suit100 so thatmaster unit266 can ensure that the correct amount of current flows through theagonist muscle502 to give the right stimulation of the agonist muscle. The master unit may also continuously measure the current of the stimulation pulses so it knows in a future stimulation how much current was required.

The master unit may also calibrate the parameters during the treatment such as increasing or decreasing the voltage or current if, for example, the patient starts perspiring during the treatment which affects the conductivity. This adjustment mechanism makes sure themuscle502 is correctly stimulated even if the external conditions change from one treatment to another treatment or throughout the course of a treatment. It is also possible to reverse the stimulation to stimulatemuscle508 instead. Theswitch control129 is then switched to an open position when stimulation pulses are sent to muscle508 while theswitch control125 is switched to a closed position so that the naturally occurring voltage signal from themuscle502 can be measured by measuring the voltage between the

electrodes

134,136 via

lines

512,515 during the time gap between the stimulation pulses sent tomuscle508.

FIG. 10 is a schematic view of asuitable circuitry arrangement513 in themaster unit266 of the present invention wherein the arrangement is changeable between either a voltage mode or a current mode which makes it possible to automatically control and adjust the current flowing through the muscle as a result of thestimulation pulse signal512. An important feature of thearrangement513 is that it is adaptive and adapts the voltage and other parameters of thestimulation signal512 based on the feedback information regarding the estimated amount of current flowing through the stimulatedagonist muscle502 as indicated by the voltage-drop across resistor R1. The estimated current is calculated from the delta voltage of the voltage-drop divided by the resistance of resistor R1 and the gain fromamplifier767. The arrangement is thus self-learning or automatic and makes the necessary adjustments of the stimulation signals based on the feedback in the pulsecurrent value signal752 that is an input to the master CPU. In other words, thearrangement513 may be used to continuously determine or estimate the amount of current flowing through theagonist muscle502 as a result of thestimulation signal512 inFIG. 9. It is thus possible to exactly provide and measure the current needed in, for example, theagonist muscle502 to effectively relax theantagonist muscle508. Thefeedback signal752 to the master unit may also used to detect an insufficient or lack of contact between body and electrodes. If there is no contact between the body and the electrodes the measured current is zero.

FIG. 11A shows a stimulationcurrent pulse531 as the current is measured and regulated byarrangement513 when the current goes through the muscle that is stimulated andFIG. 11B shows astimulation pulse519 as the delta voltage is measured across resistor R1 as the stimulation pulse leaves switch SW1 to the sub-control unit and electrodes with the current control activated (i.e. when thearrangement513 is in the current mode). It should be noted that the y-axis inFIGS. 11A-B is expressed in ampere (A) and the x-axis is expressed in time. The resulting current ofpulse531 that moves through the muscle is substantially constant with a low ripple as the current level moves or oscillates between a narrow band of a maximum value and a minimum value. This control of the current level is an important feature of the present invention. The actual current of the stimulation pulse is determined by the low ripple current as set by the current limiter signal from the CPU of themaster unit266. An important insight of the present invention is that in order to accomplish a substantially constant current it is necessary to control the current by adjusting the voltage level until the right current level is achieved. This is automatically done by thearrangement513 shown inFIG. 10. Another important feature of using a substantially constant current (with low ripple) is that when there is a poor contact between the electrodes and the skin, the constantcurrent circuit arrangement513 automatically increases the pulse voltage until a sufficient amount of current is passing through the muscle assuming that a pre-set voltage maximum is not exceeded for safety reasons. However, when the voltage is constant (as in the voltage mode) this automatic adjustment feature is not possible.

FIG. 11D shows a voltage stimulation pulse520 (wherein the voltage is constant) as the pulse leaves the switch SW1 to the sub-control unit and electrodes without the current control activated (i.e. when thearrangement513 is in the voltage mode).FIG. 11C shows the resulting current when measured as it moves through the muscle. It should be noted that the y-axis inFIG. 11C is expressed in ampere (A) over time (x-axis) while the y-axis inFIG. 11D is expressed in volt (V) over time (x-axis). The muscles first acts as a capacitor and then as a resistor so that the flank of the voltage pulse results in a highcurrent peak521 while charging the muscle (capacitance) between the electrodes during the flank of the pulse and the muscle resistance then sets the endcurrent level525 after the charging is done. In this way, the current is very high in the beginning of the treatment of the muscle and this can be very uncomfortable to the patient wearing thebodysuit100. One important advantage of using the current mode (seeFIGS. 11A and 11B) is that it prevents the initial peak of the current because the current only fluctuates betweencurrent start516 andcurrent stop518. However, as the electrode age an internal resistance builds up so that the current changes according tocurve523 that does not have a high peak in the beginning. It should also be noted that due to the internal resistance of the electrode, the current in the muscle incurve523 reaches a maximum ampere that is lower than thecurrent level525 that is reached when the electrode is new (very little internal resistance) so it may be necessary, when it is in the voltage mode, to raise the voltage inpulse power511 to compensate for the internal resistance in the electrode and so that the maximum incurve523 reaches thecurrent level525.

Theoutgoing stimulation pulse512, whether in the current mode or in the voltage mode, is sent from thearrangement513 of themaster unit266 via output from switch SW1 to the sub control units and the CPU of each sub-control unit senses the incoming pulse and the pulse also powers up the output unit535 (seeFIG. 15) of the sub-control units such assub-control unit122. It has been realized that when electrodes age over time their resistance often increases which results in an increased voltage drop at the electrodes and this results in less voltage across the muscle and the current through the muscle drops. This means that the current through the muscle has tendency to decrease although the voltage input to the electrodes of the stimulation pulses remains the same when in the voltage mode. Another factor is that the internal resistance of the muscles that are treated/stimulated may build up over time which, in turn, reduces the current that flows through the muscles when the voltage is constant (i.e. when in the voltage mode).

A CPU of themaster unit266, that is electrically connected to the arrangement513 (inFIG. 10), determines whether thearrangement513 should be in the current mode or the voltage mode according to theset signal750 sent from the CPU of the master unit to thearrangement513. Theset signal750 is either in “0” mode that may represent voltage mode so that the outgoing pulse looks likepulse520 inFIG. 11D or in “1” mode that may represent the current mode so that the outgoing pulse current looks likepulse519 inFIG. 11B. The “1” mode may be at any suitable voltage such as 3.3V, 5V or any other desired voltage level as long as it is substantially lower than the voltage ofpulse power511. When thearrangement513 is in voltage mode, the CPU of the master unit sets thevoltage511 to the desired level. When the arrangement is in the current mode, the CPU of the master units, preferably, sets the voltage inpulse power511 to a maximum allowable value (such as 40V). This is possible to do because thearrangement513 self-regulates the current and provides the required high voltage level to maintain constant current. Circuitry U1 measures the voltage over resistor R1 in both cases, i.e. whether thearrangement513 is in current mode and voltage mode, but cannot control the current when thearrangement513 is in the voltage mode. The CPU of the master unit is preferably programmed to the desired mode by software in a computing device such as a personal computer, pad or telephone. The stimulation parameters are installed in the master unit from a regular computer, pad or telephone that communicates with themaster unit266 via wired or wireless communication. One advantage of using the current mode is that if the internal resistance of the muscle has increased or there is not a good contact between the skin and the electrode then thecircuit513 increases the voltage of the stimulation signal or pulse power until the desired current flow between the two electrodes is obtained. Preferably and for safety reasons, there is a maximum limit of how much the voltage inpulse power511 can be set to. If the arrangement is in the voltage mode, i.e. the voltage of the stimulation pulse is constant at, for example, 20V, and when the resistance in the muscle increases or the electrodes wear-out over time then the current flow in the muscle drops and in some instances the current may stop flowing.

More particularly, a power unit of themaster unit266, shown in detail inFIG. 19, sends an activation pulse754 (seeFIG. 10) via resistor R2 to input onswitch controller760 of switch SW1. Theactivation pulse754 can either be in “1” mode to close switch SW1 so that thepulse power voltage511 can pass through switch SW1 that creates thestimulation pulse signal512 that continues to the sub-control units. Theactivation pulse754 can put the switch SW1 in “0” mode which opens switch SW1 so that nopulse power voltage511 can pass through switch SW1. Preferably, theactivation pulse754 is at a voltage level (for example 3.3V or 5V) that is substantially lower than the voltage level of the pulse power voltage511 (for example 20-40V). Signal oractivation pulse754 thus opens and closes switch SW1 at the desired pulse interval and pulse length as determined by the CPU of the master unit so that it is thepulse754 that sets the frequency of the pulsation of thestimulation signal512. The CPU in themaster unit266 determines the pulse length by sending the activation pulse to switch SW1. Theactivation pulse signal754 creates the pulsation of thestimulation signal512 that leaves the switch SW1 as a pulse at for example 20V. The time period the activation pulse is in “1” mode is the pulse length or duty cycle of the pulses of theoutgoing stimulation signal512. Thestimulation pulse signal512 then goes to the sub-control unit that forwards or distributes the incoming stimulation pulse to the correct electrode or electrodes and sends out the correct pulse length that was earlier sent to the sub-control unit by the master unit. The voltage level or amplitude of thevoltage pulses494 instimulation pulse signal512, when in the voltage mode, may thus be set by the CPU of the master unit and can vary between, for example, 10-100V. Voltage levels of 20V or 40V are commonly used but can thus be varied. When an “1” signal of control oractivation signal754 is sent then the switch SW1 closes so that the voltage ofpulse power voltage511 can pass through switch SW1 and the outgoing pulse length ofstimulation signal512 is controlled by the time length thesignal754 is in “1” mode before switching to the “0” mode to open switch SW1. When the switch SW1 is open, the delta voltage across resistor R1 is 0 i.e. no current flows therethrough. Theactivation signal754 comes from the CPU of the master unit so that the outgoingvoltage stimulation signal512 fromarrangement513 atoutput537 looks likepulse520 and the pulse length of the stimulation signal is determined by theactivation pulse754 because when the activation pulse opens switch SW1, i.e. switches to “0” mode, thepulse power511 can no longer pass through switch SW1 and this creates thetime gap498 between thepulses494, as shown inFIG. 9. In other words, as long as theactivation pulse754 is in the “1” mode, such as for 175 microseconds or any other pulse length, to keep the switch SW1 closed, a stimulation pulse can flow through switch SW1 and on to the sub-control units and the electrodes. In this way, theactivation pulse754 creates one pulse length of the stimulation signal until it switches to “0” mode again to open the switch SW1 that starts thetime gap498. All sub-control units in the body suit receives thepulses494 and each sub-control unit decides if it should send out the pulse or not to the electrode based on its instructions sent to the sub-control units from themaster unit266.

Whenpulse power voltage511 passes through resistor R1 and a voltage drop is formed over the low value resistor R1 (if current flows), this voltage drop is continuously measured by circuitry U1 to determine the amount of current ofpulse power voltage511 that passes through resistor R1. Circuitry U1 measures the voltage difference (for each stimulation pulse that passes through switch SW1) from the voltage at the positive pole761 i.e. prior to resistor R1 which is the voltage of the incomingpulse power voltage511 to the voltage at thenegative pole763 after the resistor R1. When the current starts flowing through the R1 and through muscle which results in the voltage drop signal at resistor R1 that circuitry U1 reads and sends out in the signal at765 andfeedback signal752. The information about the voltage difference is preferably amplified by circuitry U1 and sent in the pulse current value as avoltage signal752 to the CPU of the master unit. The CPU or a A/D converter converts the currentvalue voltage signal752 to a digital value for the CPU. Because the resistor R1 has a very low Ohm value, the voltage drop is in the order of milli-volts. The resistor R1 should be of a very low resistance to minimize the voltage loss as thepulse power511 passes through resistor R1 and onward to the switch SW1 and out as a stimulation pulse. Preferably, the

signals

765 and752 are amplified by anamplifier767 so that the

signals

765 and752 are measurable or readable by the CPU of the master unit. By knowing the resistance of resistor R1 and the amplification at circuitry U1, it is possible to determine the current. Preferably, resistor R1 should have a low resistance such as 0.1 to 10 Ohm to minimize the losses of voltage in thepulse signal512. The information in thefeedback signal752 is important because it informs the CPU of themaster unit266 when, for example, there is insufficient current which may be the result of a poor contact between the electrodes and the skin so that insufficient or no current is flowing between the electrodes mounted on the stimulated muscle and through the muscle.

Whenfeedback signal752 indicates to the CPU of themaster unit266 that the current is decreasing as determined by the voltage drop across resistor R1, it could be used by the CPU as a trigger to switch from the voltage mode to the current mode by changing thesignal750 from a “0” mode to “1” mode to close or activate switch SW2 or to increase the voltage at511 in voltage mode to increase the current. It should be noted that the change of the voltage in the voltage mode cannot be done for each pulse. Instead, it has to be over time and it is the value of the average current read value of 752 that decides if the voltage should be raised or not. It is also possible to increase the voltage of thepulse power signal511 while in the voltage mode to increase the current flowing through the muscle if it turns out that, for example, the resistance in the muscle has increased. However, it is not possible for the circuitry U1 to control the current flow for each pulse when the arrangement is in the voltage mode. As explained above, often the muscles behave like capacitors in series with the muscle and electrode resistance so that the current rapidly increases in the beginning of the pulse and then rapidly declines wherein the resistance in the muscle sets a lower limit of the current flow during the duty cycle of the stimulation pulse.

The pulsecurrent value signal752 could be used by the CPU of the master unit as a feedback signal to determine whether a previous increase of the voltage inpulse power voltage511 had any effect on the current flowing through the stimulated muscle, as measured by the voltage drop across the resistor R1. The aging of the electrodes creates a problem in that the internal resistance in the electrodes can increase over time. Another problem of using the voltage mode is that the resistance in the muscle is not linear so it is difficult to control and to make sure there is sufficient current flowing through the muscle when in the voltage mode. An average value offeedback signal752 may thus provide information to the CPU of themaster unit266 about the need to increase the voltage of thepulse voltage511 to make sure sufficient current is flowing between the electrodes. It is to be understood that the CPU may increase the voltage of thepulse power voltage511 whether thearrangement513 is in voltage mode or current mode. The “1” mode ofactivation signal754 may be at any suitable voltage such as 3.3V, 5V or any other desired voltage level.

Switch SW1 is a switch that connects thepulse power voltage511 to the sub-control units that then forward the stimulation pulse signals512 to the selected pair of electrodes. As indicated above, the resistance of resistor R1 is so low that it does not really affect the voltage of theoutgoing pulse signal512. The control oractivation pulse754 thus repeatedly opens and closes switch SW1 to disallow or allow, respectively, thepulse power511 to pass through the switch SW1 asstimulation pulse signal512 and circuitry U1 continuously measures the voltage drop across low value resistor R1 that the current causes at resistor R1 to indirectly determine the amount of current flowing through the muscles that are treated.

It should be noted that circuitry U1 measures the current (i.e. voltage drop across the resistor R1 caused by current through resistor R1) regardless whether thearrangement513 is in current mode or in voltage mode. When switch SW2 is open (“0” mode), i.e. the arrangement is in the voltage mode, then the circuitry U1 can merely measure the voltage drop over resistor R1 but cannot effectively control the outgoing current in the outgoingstimulation pulse signal512 that leaves atoutput537 and goes to thesub-control unit122. Theincoming activation pulse754 from the CPU of the master unit is a low-level pulse that enables (when in “1” mode) the highvoltage pulse power511 to pass through switch SW1 by closing the switch SW1 to create the outgoingstimulation pulse signal512 atoutput537. Thepulse power511 may have any suitable voltage, such as 10-40V, as controlled by the CPU of the master unit.

When switch SW2 is closed (“1” mode), as set by the digital mode (“0” or “1”) of the incoming set signal750 from the CPU of themaster unit266, then circuitry U1 can affect the outgoing current of thestimulation signal512. The circuitry U1 can temporarily open switch SW1 by connecting the SW1 control pin to GND during theactivation signal754 when the current, as determined by the measured voltage drop over resistor R1, has increased to an upper threshold value (stop current) in circuitry U1. When circuitry U1 detects that the voltage drop across resistor R1 has increased so that corresponding current has reached the upper threshold value, i.e. the stop current value (as set by the current limit pin on circuitry U1759) then circuitry U1 connects the SW1 control pin to GND to stop theactivation pulse754 so that switch SW1 opens. When the switch SW1 is temporarily opened by circuitry U1 then the delta voltage across resistor R1 declines until acurrent start516 value is reached when the circuitry U1 releases SW1 control pin from GND so thatpulse754 closes switch SW1 again by allowingpulse754 to close switch SW1. More particularly, when the circuitry U1 senses that the voltage-drop (delta V) has declined so that start current516 value has been reached then circuitry U1 releases the SW1 control pin and switch SW1 closes again so that thepulse power voltage511 can continue to pass through the switch SW1 and the delta voltage across the resistor R1 starts increasing because the current starts flowing through the muscle again. The current of theactivation pulse754 to SW1 control pin is limited by resistor R2 when circuitry U1 connects signal754 after resistor R2 to GND. When the circuitry U1 detects that the voltage-drop across resistor R1 is such that thecurrent start516 has been reached, then circuitry U1 releases the SW1 control pin and switch SW1 closes again and the voltage of the pulse is connected to the electrodes and the current can start flowing through the muscles and electrodes and the current increases until stop current518 when thecomparator756 with integrated hysteresis stops theactivation signal754 again so that switch SW1 opens. In this way, circuitry U1 controls the current flow in the stimulated muscle during the pulse duty cycle ofstimulation pulse512 when switch SW2 is closed or active. It is to be understood that the fluctuation of the current between start current and stop current is so rapid that there is not enough time for the CPU to be involved. This is why thecomparator756 is used. The voltage to switch SW1 is generated via resistor R1 and theactivation pulses754 to switch SW1 that are sent by the CPU of themaster unit266 and the switch SW1 is activated or de-activated by the activation/control signal754. When the activation/control signal754 is temporarily stopped by circuitry U1 and when switch SW2 is in the current mode this in turn opens the switch SW1 so that no pulse power current511 can flow through switch SW1. When the CPU of themaster unit266 sends out a pulse activation command (i.e. “1” command) in thecontrol signal754 via resistor R2 then the switch SW1 closes and thepulse power voltage511 can pass through switch SW1. When thesub-control unit122 then sends the pulse to a selected electrode pair and muscle, the current flow starts and this creates the voltage drop over resistor R1. This voltage drop across resistor R1 is continuously measured by circuitry U1 that converts it to the feedback signal that is sent to the CPU of the master unit as the pulsecurrent value signal752. The CPU in themaster unit266 reads the voltage drop information insignal752 as a value of the current of the outgoing pulses ofstimulation signal512. When the CPU of the master unit has selected the current mode (i.e.set signal750 is in the “1” mode) then the switch SW2 is activated or closed. The corresponding current (as measured by the voltage across resistor R1) that is measured by circuitry U1 is compared to the upper threshold value or current limit of the current as set by the CPU of the master unit. When the current has reached the upper threshold voltage value (stop current518 inFIG. 11B) then the transistor or switch762 connects the SW1 control pin to GND to short-circuit the control/activation signal754 after resistor R2 (wherein resistor R2 is a current limiter) as determined by thecurrent limiter comparator756 in circuitry U1. This assumes that the voltage of thepulse power511 is high enough, considering the total resistance in the system, so that the current would increase to a value higher than stop current518. When the current reaches the upper threshold, thecurrent limiter comparator756 short-circuits thesignal754 after resistor R2 so that switch SW1 opens and the current flow stops and the current starts decreasing. When the current has decreased to the start current516 (as shown inFIG. 11B), theswitch762 disconnects the SW1 control pin from ground GND so thatpulse power511 can pass switch SW1 and the current can start flowing again. Thepulse signal754 is in “1” mode (at 3.3-5V) before resistor R2 but in “0” mode (i.e. the voltage is 0) after resistor R2 whenswitch762 is closed and leadspulse signal754 toground758. Resistor R2 protects the CPU when there is a short-circuit to ground because it limits the amount of current that can flow therethrough. The resistor R2 could be in a range of 5-15 Ohm and more preferred about 10 Ohm. Theswitch controller760 senses the change ofpulse signal754 to “0” mode and opens the switch SW1. The closing and opening of the switch/transistor762 are controlled by thecurrent limit comparator756. Thecomparator756 has acurrent limit inlet757 that is controlled by the CPU of the master unit so that the CPU can set the value of the current by sending avoltage value759. The difference between start current516 and stop current518 is preferably constant and thesignal759 sets the level or limit of, for example, the stop-current518 which means it indirectly also sets the limit for start current516 since the difference (delta) between the start current and stop current preferably remains the same and is determined by the hysteresis ofcomparator756. Preferably, the voltage difference should typically be about 20 mV but can be set to another value also. In this way, thesignal759 can increase or decrease the average voltage value (which is equivalent to an average current value) that is sent to the CPU of themaster unit266 insignal752. Thecomparator756 compares the value of the amplifiedvoltage drop signal765 with the current limits of thevoltage value759 and when thevoltage drop signal765 has reached the current limit (stop current518 inFIG. 11B) then thecomparator756 closes the switch/transistor762 so that theactivation pulse754 goes toground758 and the switch SW1 opens. This stops the current through the resistor R1 and the current of thestimulation signal512 decreases and when the delta voltage has decreased to a level that is equivalent to start current516 (seeFIG. 11B) then thecomparator756 opens theswitch762 so that switch SW1 closes again and the current of the stimulation signal starts increasing as shown by the increase of thevoltage drop signal765 from circuitry U1. Theswitch762 is kept open until the current, as indicated by the delta voltage across resistor R1, has increased to the stop current value and theswitch762 is closed again bycomparator756. Thecomparator756 may have pre-set hysteresis values so that the comparator has an upper level and a lower level that it compares the current value against. Preferably, the comparator has one built-in hysteresis value that corresponds to the current start value516 (and current stop value518) and the CPU of the master unit sets the value for stop current518. The opening and closing ofswitch762 are extremely quick (such as nanoseconds) and occurs during the duty cycle of thepulse494 so that theswitch762 is opened and closed many times during the pulse. It is important that the voltage of thepulse power512 is sufficiently high so that the current can increase from the start current516 to stop current518 when the arrangement is in the current mode. The amount of current is determined by the resistance in the muscle, electrodes and wiring.

The current thus fluctuates between the upper stop current518 and lower threshold (start current516) values, as shown inpulse519 inFIG. 11B. The opening and closing of switch SW1 occur during the duty cycle ofstimulation pulse494 so the time frame is very short i.e. nanoseconds. It should be noted that the size of the current that flows through the muscle, i.e. between the electrode pairs mounted on the muscle, is partially decided by the natural resistance in the muscle and which current that is selected by thesignal759.

It may also be possible to apply the principles of the present invention to, for example, a hand or wrist that is stiff relative to the lower arm so that the hand is fixed in a downward position and the patient is unable to rotate the hand in an upward direction. Today, the hand must be forcibly moved in the upward direction. This is very unpleasant to the patient. An important feature of the present invention is to first send stimulation signals to the agonist muscle located on the upper side of the lower arm to indirectly relax the tense antagonist muscle located on the lower side of the lower arm. The amount of relaxation of the antagonist muscle may be determined by measuring the amount of voltage-out (EMG) in the antagonist muscle and how this has changed when it is connected to an electrode pair. After the antagonist muscle has been relaxed for a certain time period so that there is less resistance of the muscle to be extended, a relatively high voltage or current signal is sent to the agonist muscle located on the upper side of the lower arm so that the agonist muscle shortens enough to cause movement/contraction of the agonist muscle (while the relaxed antagonist muscle extends) to lift the hand at the wrist in the upward direction relative to the lower arm without using an external mechanical force. This stimulation signal may have a higher voltage, a higher predetermined current or a longer pulse length (duty cycle) than the parameters used to merely stimulate the agonist muscle (in order to relax the antagonist muscle) so that the stimulation signal contracts the stimulated muscle in order to move the arm.

FIG. 12 is a top view of anelectrode400 of the present invention whileFIG. 13 is a cross-sectional side view of the electrode. Preferably, theelectrode400 includes a conductive rubber material that is covered by a conductive layer of gold, silver or any other conductive material. The electrode should have no sharp edges. The electrode may, for example, be made of a conductive woven fiber or silver tread, gold thread, copper wires, stainless steel surgical wires and silicon wires.

Theelectrode400 is an illustrative example of an electrode and could be one of the

electrodes

134,136 etc. shown in thebody suit100 inFIG. 4. Theelectrode400 has a protrudingmid-section402 that is made of a thin electrically conductive rubber, with metal plating such as gold or any other suitable conductive material. The mid-section402 may contain a soft filling material and/or be hollow so that it is inflatable and deflatable. Preferably, thefabric404 of thebody suit100 extends over theouter edge406 of the mid-section402 so that the fabric overlaps anouter portion408 of the mid-section402. Thefabric404 is attached to theouter portion408 in a suitable way such as using an adhesive. One advantage of using a conductive metal plating is that it slides better on the skin of the patient wearing thebody suit100. Conventional electrodes made of a rubber material has a high friction against the skin that makes it harder to take on and off the body suit. A low friction coefficient of the mid-section402 is important when the body suit is put on and taken off the patient so that the electrodes slide on the skin. A backside of theelectrode400 may have an electrically conductive layer of a rubber material. Preferably, thefabric404 outside theouter portion408 is sewn to the body suit. The mid-section402 has an electricallyconductive connector410 that extends outwardly beyond theouter portion408. Theconnector410 may overlap a flexibleconductive wire412 that is connected to one of the sub-control units. Anouter portion414 of theconnector410 may be attached to anouter portion416 of thewire412 such as by sewing them together. The mid-section402 may be filled with a softspongy material418 so that the mid-section402 protrudes away from thefabric420 of thebody suit100 so that it is urged against theskin422 of the patient wearing thebody suit100 to improve the contact between the skin and the electrode. Theelectrode400 may also include atubular portion424 that extends through thefabric404. Thetubular portion424 may be connected to a balloon-shapedpump426 that may be used to inflate the inside401 ofelectrode400 so that it expands and protrudes more to further improve the electrical contact between themetal mid-section402 and theskin422. An important feature is that thetubular portion424 and/or the balloon-shapedpump426 may be removably attached so that they may be removed and connected to another electrode that needs to be expanded by pumping it up. It is also possible to provide the electrodes with a valve to release the pressure/air when the mid-section402 becomes too hard and the valve automatically closes when thepump426 is removed. The rear-part of thefabric404 is sewable so that the electrodes can be sewed to the fabric of thebody suit100. Preferably, only the mid-section402 is pumped but not theconnector410. The electrodes can also be woven into the elastic bodysuit wherein the electrodes are woven with conductive threads. The conductors to the sub-control units can also be woven into the bodysuit with conductive thread so that they can be connected to the sub-control units and the sewable connections are sewed together.

extensions

124b,130band wires124a,130a, respectively, from themaster unit266. Thedata units530 are preferably sent to the sub-control units during the start up so that the sub-control units receive instructions in the data units about which and when electrodes should be activated. In other words, thedata units530 are first sent to the sub-control units with instructions about what to do with thepulses494 that comes after thedata units530. Themaster unit266 may provide power to the sub-control units via the wires extending from the master unit to the sub-control units. The data units may include information about to which electrodes and which combinations of electrodes and pulse length, the sub-control unit should distribute thepulses494 to when they arrive from the CPU of themaster unit266. All the sub-control units receive the data but they have different addresses so the master unit can address the data to the right sub control unit. If the data information has the wrong address for a sub-control unit then the sub-control unit does not read it. No data should be sent during the stimulation pulses and, preferably, the stimulation pulses to the sub-control units are generated from themaster unit266 that also controls the data flow. As indicated above, instead of using a serial data-bus with two wires, it is possible to also use three wires wherein two of the wires are used for power while the third wire is use to carry the stimulation pulses and that data can be sent via a suitable wireless technology. It is also possible to use two wires used to provide the power while the data is sent by wireless technology. It is also possible to use a one-wire data transmission such as sending data between the master unit and the sub-control unit in the positive or negative wire. The body suit can also have multiple master units so that, for example, one master unit stimulates an arm and the other master unit is used to stimulate the legs. The master unit can also have several power, data and pulse outputs circuits so that it drives several independent circuits such as running the front part of the suit independent from the back side of the suit or the upper part of the suit independent from the lower part of the suit.

FIG. 15 is a schematic illustration of how the direction of the current between two electrodes via a muscle can be changed so that a positive pole is changed to a negative pole and vice versa. It may also be possible to intermittently switch the current flow so that the current first flows from an insertion or first end of the muscle to an origin or second opposite end of the muscle and then from the origin or second end to the insertion or first end i.e. the current goes back and forth through the muscle. It may also be possible run in one direction for more than one cycle before the direction is switched to the opposite direction. An important and surprising insight is that the switching of the direction of the current improves the effectiveness of the stimulation by reducing the build-up of natural resistance in the treated/stimulated muscle over time and reduces the risk of red irritations being created on the skin of the patient. It has been discovered that the muscles have a capacitor effect in the muscle, similar to a capacitor. Preferably, theCPU531 of thesub-control unit122 determines which current direction should be used based on instructions received from themaster unit266. It is possible to switch the direction during each stimulation pulse, such as after 50% of the pulse length the polarity is shifted or shifted several times during one pulse. It is possible to switch the direction after each stimulation pulse that is sent to the electrodes or numerous pulses may be sent, such as 10 pulses, before the direction of the current is switched and then, for example, send another 10 pulses before the direction is switched again. It is of course possible to run the current in the same direction through the muscles without switching the direction.

TheCPU531 ofsub-control unit122 receives power from themaster unit266 viapower line533 and also the pulse (seepulse input782 inFIG. 16) so that the CPU knows that a pulse has arrived to the sub-control unit. With reference toFIG. 15, theunit122 has anoutput unit535 that receives thepulse signal512 sent from theoutput537 of themaster unit266. Theoutput unit535 has aground706. Thepulse stimulation signal512 from themaster unit266 is sent viaarrangement513 shown inFIG. 10. TheCPU531 of thesub-control unit122 has an I/O unit539 that sends instructions about when to send out pulses vialine543 to theoutput unit535. More particularly, theunit539 may send out either a “0” instruction or a “1” instruction wherein the “1” instruction that may represent that theoutput unit535 leads out the stimulation output pulse for a certain time period to forward theincoming stimulation pulse512 from themaster unit266 to the electrodes. The “0” instruction may represent that theoutput unit535 is switched to a closed position to close the output function so that nostimulation pulse signal512 can pass through theoutput unit535. TheCPU unit531 also has an I/O unit541 that sends out “0” or “1” instruction about which current direction to use vialine545 to theoutput unit535. The “0” instruction may represent one direction while the “1” may represent the opposite current direction. Ifelectrode134 is the positive pole andelectrode136 is the negative pole then the current flows fromoutput unit535 toelectrode134 viawire134athrough the muscle and intoelectrode136 and viawire136aback tooutput unit535 ofsub-control unit122 to ground (GND). The

arrows

702 and704 between the

electrodes

134,136 indicate that the direction of the current flow can be changed. As shown inFIG. 5, thesub-control unit122 is not limited to

just extensions

134b,136bthat are connected to

electrodes

134a,136a, respectively but preferably has at least 8 such extensions. It is also possible to create combinations so that, for example,

electrodes

134 or136 are combined with one or many other electrodes so that complex treatment patterns may be created by theCPU531 with instructions from the CPU in themaster unit266.

FIG. 17 illustrate how adistribution unit770 can receive power, data and pulses and distributes signals to theCPU531 andoutput units535 of the sub-control units such as sub-control unit122 (also shown inFIG. 15). In general, the serial data-bus information (i.e. power, data and pulses) that are eventually transmitted in, for example, the two

wires

124,130 are first split up or divided into five separate lines that are connected to the CPU and the output units of the sub-control unit. Preferably, thedistribution unit770 is part of thesub-control unit122 and a part of themaster unit266 unit.FIG. 16 is similar toFIG. 15 but shows more details and includes 8

electrodes

134,136,138,140,142,144,146 and148 instead of just 2

electrodes

134,136 and four

output units

535a,535b,535c,535dinstead of just the oneoutput unit535 shown inFIG. 15. In this system, themaster unit266 is communicating with the sub-control units and electrodes by using only two wires, such as

wires

124 and130 inFIG. 17, that are electrically connected to all the sub-control units in the bodysuit and other wire pairs going to themaster unit266. One wire, such aswire124 inFIG. 17, could carry VCC power at, for example, +3.3V,data1 pulses530 and thestimulation pulses494 received from themaster unit266 to the sub-control units. The other wire, such aswire130, could serve as ground (GND) and carrydata2 pulses772. Thedata 1pulses530 anddata 2pulses772 relate to communication between the master unit and all the sub-control units. Other data bus constructions may also be used. Theunit770 separates data1

pulses

530 from VCC by unit C1 so that the data goes to a data input Data IN 1774 of the CPU531 (best shown inFIG. 16).Data2 pulses772 are separated from GND byunit770 by unit C2 to an input Data IN 2776 of theCPU531. Thepulses494 of stimulation signals512 to the electrodes are sent in to the sub control unit when no data is sent. Thispulse494 is read by theCPU531 atinput782 viaresistor780 and zener diode D1 (inFIG. 16) to apulse input782. Thispulse494 also goes to the535a,535b,535cand535das pulse-in796 and as pulse-out798 to the electrodes when the sub-control unit sends out the pulses. TheCPU531 can keep the pulse length of thestimulation signal512 the same or shorten it by activating the allow pulse-out794 function. The same principle applies to all theother output units535b-d.

Thearrangement770 inFIG. 17 provides a protection of the electronic components so that the high voltage pulse does not destroy any component that cannot withstand the high voltage. Theunit770 distributes a VCC power signal784 (such as +3.3V) to thesub-control units122 to provide power to the components of thesub-control unit122 and ground viaGND786. The CPU controls the current direction of

output units

535a,535b,535cand535dregarding the

current direction

788a,788b,788c,788dof the electrodes and how to switch the polarity of the

electrodes

134,136,138,140,142,144,146 and148 inFIG. 16 as illustrated by the arrows between the electrodes.

Only arrows

790,791,792 and793 illustrate that the electrode pair may also change so that, for example,electrode134 is paired withelectrode138 instead of withelectrode136. It is to be understood, that the electrodes may be paired in any combination and that the electrode pairs134 and136 and electrode pairs134 and138 are merely examples. This meanselectrode134 may, for example, be the positive pole whileelectrode138 is the negative pole. Theelectrode134 may be paired with any other electrode. It is important that the electrodes may change polarity in order to make it possible to pair any of the electrodes with one another since one electrode must be the positive pole and the paired electrode must be the negative pole. The change of polarity of the electrodes makes it possible to stimulate the muscles in new and different ways. This is not possible to do when the polarity of the electrodes is fixed.

The

serial data

1 and 2 between the master unit and the sub-control unit include information about how the pulses should be sent out from the sub-control unit to the electrodes. When a stimulation pulse arrives to the sub-control unit viapulse input778, theCPU531 must first realize or be activated by the stimulation pulse that has arrived to the sub-control unit. This is determined byinput782. Then the CPU of the sub-control unit selects to which electrode pair the stimulation pulse should be sent to and the CPU sets the current direction and then the CPU allows the stimulation pulse to pass to pulse out on

units

535a,535b,535cor535d. Preferably, the pulse length or duty cycle (such as 200 microseconds) of the stimulation pulse received from the master unit vialine778 should be slightly longer than the max pulse length (such as 175 microseconds) of the stimulation pulse that is sent from theoutput unit535ato the

electrode

134 and136. The exact values of the pulse lengths are not important as long as the pulse length of the incoming pulse is slightly longer than the outgoing pulse to the electrodes. The sub-control unit knows the stimulation pulse length so that the sub-control unit sets the correct pulse length. The difference (such as 25 microseconds) in the pulse length enables theoutput unit535ato receive the incoming stimulation pulse and send the stimulation pulse to the correct electrode and with correct length.

FIG. 18 is a schematic view of thebody suit100 reading the brain signals800 of the patient who wears thebody suit100 so that the electrodes measures the weak voltage signals from the brain. Only the upper part of thebody suit100 is shown inFIG. 18 and the other portions of thebody suit100 are identical to the body suit shown inFIG. 4 that also includes all the reference numerals. Thesuit100 has asixth connector802 that has apositive pole804 electrically connected to wire155 via an elastic andflexible wire806 and anegative pole808 electrically connected to wire157 via an elastic andflexible wire810. Thesixth connector802 has apositive pole812 that is electrically connected to a seventhsub-control unit814 via an elastic andflexible wire816 and anegative pole818 that is electrically connected to thesub-control unit814 via an elastic andflexible wire820. Thesub-control unit814 is different from the other sub-control units in that is does not have any muscle stimulation function but is used to receive information from the electrodes about the brain signal activity of thebrain800 and transmits this information via the serial data-bus to themaster unit266. Themaster unit266 receives the information and determines which stimulation that should be activated. Thesub-control unit814 can provide input to the system so that the system can perceive with the help of these signals which body parts the person wearing the body suit wants to move. This is where themaster unit266 steps in to interpret the brain voltage signals (EEG signals) sensed by the electrodes inside theheadband832 or at the lower neck level or upper spinal cord to learn which muscles that must be activated to carry out the desired muscle movement such as moving an arm. The present invention is not limited to merely reading signals at the brain level. It is also possible to use the body suit to read the signals that the brain send at the lower neck level or upper spinal cord in order to read request for movements without requiring the patient wear a heatset or head-piece with electrodes. The body suit can be used to measure signals at upper neck muscles, jaw muscles, sternocleido mastoideos and stratetius muscles to read brain signals without needing a headset

Themaster unit266 may have a database that includes previously recorded and stored brain voltage wave patterns for various muscle movements so that when a certain brain voltage wave pattern is received, the master unit may first analyze the pattern of the incoming brain signals and then search its database to find the matching brain signals pattern that is then translated into which electrodes should be activated and in which order to carry out the desired muscle movement or stimulation such as the movement illustrated inFIG. 9. Thesub-control unit814 contains a CPU that saves and analyzes the incoming data from the

electrodes

824,828 and send data tomaster unit266 that determine which electrodes should be activated in the suit. It should be understood thatsub-control unit814 sends out data via the serial data-bus to themaster unit266 when the master unit asks for data.

Similar to the sub-control units in the modules, thesub-control unit814 is electrically connected via awire822 to anelectrode824 and via awire826 to anotherelectrode828. It should be understood that more than two wires may be used between thesub-control unit814 and theconnector802. The electrodes are preferably urged against thehead830 by anelastic headband832.FIG. 18 illustrates only two electrodes but many more electrodes may be used as required to monitor the brain voltage signals of thebrain800 to determine which muscles the person is thinking about using. The body suit may be used to read signals at sternocleidomastoid muscle, temporalis muscle, masseter muscle, trapezius muscle, suboccipital muscles, cervical spinal erector muscles. The body suit can be used to conduct measurement of key muscles in head and neck.

EMG measurements in a first muscle can be recorded and stored. The recording of EMG-activation can be paired to activation of any other muscle in the patient/user by using the electrodes in the suit. Activation of any other muscle, through the suit electrodes, can be connected to activate of the first muscle. For example, the user could clench the teeth and so forth activate the masseter muscle. The EMG signal from masseter could be the starting signal to activate contraction of knee extensor muscles. A patient/user with tetraparesis, after cervical spinal cord injury, could regain the ability to stand through activation of jaw closing muscles. Another example is that the shrugging of shoulders leads to activation of the trapezius muscle, measured by EMG-electrodes in the bodysuit. Activation of trapezius could be paired to activation of the arm-lifting and elbow-flexing muscles. In this example, the shrugging of the shoulder could lead to the user giving someone a hug.

FIG. 19 is a schematic illustration of themaster unit266 that, preferably, includes a disposable orre-chargeable battery850, such as 6-10 volts (or higher), to electrically drive themaster unit266 and all sub-control units. Preferably, the battery cannot be charged while in the master unit and in the suit to prevent any undesirable voltage going into thebodysuit100 during charging. An external battery charger should be used. Thebattery850 is electrically connected to thepower unit852 that provides the power to the central processing unit (CPU)854,display860 and all the master unit circuitry513 (also shown inFIG. 10) and all sub-control units. The power module orunit852 also has a step-upvoltage circuit856 that steps up the voltage of thestimulation pulse voltage511, that uses to generatestimulation pulse512 sent to the sub-control unit to, for example, about 20V or 40V wherein the power voltage to thearrangement circuit513 and CPU may, for example, be 3.3V or 5V. In other words, thecircuit856 increases the voltage of the battery such as 3-10V to about 20-40V. The exact voltage used in thestimulation pulse512 is determined by theCPU854 and its software. Themaster unit266 also has a safety circuit module inhardware858 that makes sure no pulse length in the stimulation pulse is longer than a predetermined maximum time period. The reference to CPU inarrangement513 inFIG. 10 means there is an electrical connection to theCPU854 that controls the input/output to receives information from and send information to thearrangement513. The master unit has auser interface unit860 that is an interface so that the therapist can set, see and change parameters and programs of the master unit and also receive the data from the master unit collected during earlier stimulating runs. Thedisplay unit860 may include a display window862, switches as start/stop864 that starts or stops the running of the stimulation program such as a stimulation program and makes it possible to select and change stimulation programs and pause the run of the stimulation program. Theunit860 has abuzzer866 that provides sound/warning signals andLED diodes868 as indicators. Themaster unit266 also has acommunication module870 for Bluetooth, Wi-fi and USB data connections in order to communicate with the sub-control units in thebodysuit100 and with computers as PC, pad or phones and with the Internet and cloud services. Themaster unit266 has aninterface872 that connects all the wiring that goes to the sub-control units to send five types of signals including power, positive pole, negative pole, superposed data and stimulation pulses equivalent toFIG. 17 (see ref. no.770).

FIG. 20 is substantially similar toFIG. 9 but includes amovement sensor517 that registers movement of thearm509. The movement sensors may be placed on any part of thebody suit100 where measurement of movements is desired, the placement of thesensor517 on the elbow of thearm509 is merely an illustrative example. Information about the movement sensed by thesensor517 is sent to thesub-control unit122 via

wires

519,521 and provides feedback to thesub-control unit122 regarding the effect ofstimulation signal512 on the body movement when thesignal512 is strong enough to causemuscle502 to contract in order to move thearm509 or when the user of the body-suit can move the arm. In this way, the sub-control unit receives information about whether the arm has moved and how much it has been moved. With the movement sensors the system can obtain information about movement even micro-movements created with the stimulation pulses. This information is also be sent to themaster unit266 so that the parameters of thestimulation signal512 can be adjusted accordingly. It is also possible to merely read micro-movements at the muscle level to determine whether the “sweet-spot” has been reached i.e. the correct stimulation of the muscle that triggers the response from the spinal cord without causing a physical movement of, for example, the arm.

FIG. 21 is a schematic view of a frontside of a garment of an elastic andtight body suit1000 of the present invention. Thebody suit1000 is substantially similar tobody suit100 shown inFIGS. 4 and 18 except thatbody suit1000 also includes a right-hand glove module1002, left-hand glove module1004,right sock module1006 and aleft sock module1008. The detailed description ofbody suit100 also applies tobody suit1000. For clarity, only the differences betweenbody suit1000 andbody suit100 are here described. One important feature ofbody suit1000 is that it enables the patient wearing the suit to move the hands, fingers, feet and toes by reading brain signals and by electrically relaxing and stimulating muscles, as described in detail above. Thesub-control unit122 ofright arm module102 has an elastic andflexible wire1010 electrically connected to apositive pole1012 of a right-hand connector1014 and an elastic andflexible wire1016 electrically connected to anegative pole1018 of the right-hand connector1014. Similar to the other connectors described in detail above, right-hand connector1014 electrically connects the right-hand glove module1002 to theright arm module102.

Right-hand glove module1002 has a right-hand sub-control unit1020 that is electrically connected to

electrodes

1022,1024 and1026 via elastic and

flexible wires

1022a,1024aand1026ato relax and stimulate muscles in thehand1028, as described in detail above. Thesub-control unit1020 is electrically connected to apositive pole1030 and to anegative pole1032. The sub-control unit is here shown with 3 electrodes but it can have more or fewer electrodes. This applies to all the sub-control units ofFIG. 21.

Thesub-control unit228 ofleft arm module106 has an elastic andflexible wire1034 electrically connected to apositive pole1036 of a left-hand connector1038 and an elastic andflexible wire1040 electrically connected to anegative pole1042 of the left-hand connector1038. The left-hand connector1038 electrically connects the left-hand glove module1004 to theleft arm module106. Left-hand glove module1004 has a left-hand sub-control unit1044 that is electrically connected to

electrodes

1046,1048 and1050 via elastic and

flexible wires

1046a,1048aand1050ato relax and stimulate muscles in thehand1052, as described in detail above. Thesub-control unit1044 is electrically connected to apositive pole1054 and to anegative pole1056.

Thesub-control unit294 ofright leg module110 has an elastic andflexible wire1058 electrically connected to apositive pole1060 of a right-foot connector1062 and an elastic andflexible wire1064 electrically connected to anegative pole1066 of the right-foot connector1062. The right-foot connector1062 electrically connects the right-sock module1006 to theright leg module110.Right sock module1006 has a right-foot sub-control unit1068 that is electrically connected to

electrodes

1070,1072,1074 and1076 via elastic and

flexible wires

1070a,1072a,1074aand1076ato relax and stimulate muscles in theright foot1078, as described in detail above. Thesub-control unit1068 is electrically connected to apositive pole1080 and to anegative pole1082.

Thesub-control unit320 ofleft leg module112 has an elastic andflexible wire1084 electrically connected to apositive pole1086 of a left-foot connector1088 and an elastic andflexible wire1090 electrically connected to anegative pole1092 of the left-foot connector1088. The left-foot connector1088 electrically connects theleft sock module1008 to theleft leg module112. Left-sock module1008 has a left-foot sub-control unit1094 that is electrically connected to

electrodes

1096,1098,1100 and1102 via elastic and

flexible wires

1096a,1098a,1100aand1102ato relax and stimulate muscles in theright foot1104, as described in detail above. Thesub-control unit1094 is electrically connected to a positive pole1106 and to anegative pole1108. It is thus also possible to measure movements and voltage signals from the feet and hands of the patient wearing the body suit.

Because thebody suit1000 of the present invention has sub-control units it is possible to extend the stimulation to the hands and feet by activating electrodes on the glove and sock modules. It is also possible to remove one module such asarm module102 and electrically connectconnector128 directly to right-hand connector1014 so that themaster unit266 can communicate with thesub-control unit1020 to control the electrodes connected to thesub-control unit1020. This principle of removal of a module applies to all the other modules i.e. that one module can be removed and then the connectors can be directly connected to one another.

In operation, it is possible to ramp up or gradually increase the pulse length, voltage level of the stimulation pulse and the current level such as in the beginning of the stimulation treatment to make the treatment more comfortable to the patient. In other word, the treatment starts with a mild stimulation that is gradually increased to make the stimulation signal more powerful when the patient has become used to feeling the stimulation signal. When necessary it is also possible to ramp down the pulse length, voltage level of the stimulation pulse and the current such as at the end of the treatment or when the stimulation pulse is too strong or powerful to the patient (i.e. when the stimulation signal causes undesirable movement of, for example, an arm). More particularly, when thearrangement513 is in the current mode, it is effective to gradually increase the current as set by the current limits insignal759 assuming that the voltage ofpulse power511 is high enough for the current at the stop limit current518. The ramping up period may be between 5-10 minutes before the full treatment current is reached. The treatment period may be 40-60 minutes. The treatment period may be longer or shorter. When the treatment period is over, it is possible to ramp down i.e. gradually reduce the current for 5-10 minutes by gradually lowering the current limits insignal759 to make it comfortable to the patient. The pulse length may also be ramped up in a similar way so if the pulse length is 175 microseconds the first pulse may be 30-50 microseconds long and this is gradually increased until the full pulse length is reached in 5-10 minutes. The pulse length can also be ramped down at the end of the treatment in a similar way over 5-10 minutes. The ramping up and down of the pulse length applies to both the voltage mode and the current mode. It is less effective to raise the voltage of thepulse power511 when thearrangement513 is in the current mode because thearrangement513 is then self-regulating and thecomparator756 sets the current as the result of the current limit level provided insignal759. The only voltage requirement, when in the current mode, is that it must be high enough to accomplish the stop current518. When the current of thestimulation signal512 is ramped up this is reflected in the pulse current value signal752 (seeFIG. 10) that goes to the CPU of themaster unit266 so that the CPU receives the feedback that the current is actually gradually being increased as a result of raising in the current limit insignal759 that is also sent by the CPU of themaster unit266. Because the fluctuations betweencurrent start516 andcurrent stop518 are shorter (in nanoseconds range) than thepulse length495, the voltage value insignal752 represents an average of the voltage or the equivalent current that fluctuates between thecurrent start516 andcurrent stop518. In this way, the pulse currentaverage value signal752 acts as a feedback signal to the change of the current level insignal759. The corresponding current value insignal752 is particularly important when thearrangement513 is in the voltage mode because then the value of the actual current flowing in one pulse through the muscle is unknown or at least difficult to control, as shown inFIG. 11C. When in the voltage mode and if the corresponding average current insignal752 is too high then the CPU of themaster unit266 can lower the voltage of thepulse power511. Similarly, when the average current is too low, as reported insignal752, then the CPU can increase the voltage ofpulse power511 when in the voltage mode until the desired current is reached although it is difficult to know the exact current that flows through the muscle in each pulse, as shown inFIG. 11C.

When in the current mode and if the current instimulation signal512 is too high then movement sensor517 (seeFIG. 20) can sense a movement or contraction of a muscle, for example, thearm509 as reporting in

signals

519,521 going to thesub-control unit122 and thesub-control unit122 forwards the movement information to themaster unit266 that lowers the current limits insignal759 going to thecomparator756 of circuit U1 when thearrangement513 is in the current mode (seeFIG. 10) the sub-control unit can also shorten the pulse length to lower the stimulation. When the current is too high and thearrangement513 is in the current mode (signal750 is in “1” mode) then it may also be effective for the CPU of themaster unit266 to shorten the duty cycle orpulse length495 of eachpulse494 of thestimulation signal512 or lowering thecurrent limit level759. It is also possible for the CPU of themaster unit266 to shorten the pulse length when thearrangement513 is in the voltage mode although the current that flows through the muscle includes the peak521 (seeFIG. 11C) in the beginning of the pulse so a slight shortening of the pulse length does not remove thepeak521 so the stimulation signal may still be uncomfortable to the patient wearing the body suit even when the pulse length has been slightly shortened such as from 175 microseconds to 100 microseconds since thecurrent peak521 occurs in the beginning of thepulse494. The current mode does not have this drawback because the current only fluctuates between thecurrent start516 and current stop518 (seeFIG. 11B).

It is also possible to measure the difference between the voltage signals from

electrodes

138,140 that are mounted on theantagonist muscle508. This voltage difference is amplified by amplifier127 (seeFIG. 9) and stored in thesub-control unit122. Thesub-control unit122 may then at time intervals report the voltage differences to themaster unit266 so that the master unit can determine whether the parameters of thestimulation signal512 ofmuscle502 should be changed. If the voltage difference is high this means themuscle508 is not sufficiently relaxed and the stimulation ofmuscle502 should increase by raising the parameters of thesignal512 such as raising the current when thearrangement513 is in the current mode or raising the voltage when thearrangement513 is in the voltage mode.

It is also possible to connect more than one master unit to the bodysuit so that one master unit runs a first program in a first module of the bodysuit and a second master unit runs a second program in a second module wherein the second program is different from the first program. In this way, the stimulation pulses, frequencies etc. associated with the first program are independent of the stimulation pulses, frequencies associated with the second program. Many master units can be connected to the connectors of the bodysuit. If only the arm module is used then themaster unit266 can be connected atconnector128 orconnector194. Preferably, the master unit is or the master units are connectable to any of the connectors on the body suit.

FIGS. 22A-22C illustrate the drawbacks of using the voltage mode. It is to be understood that the resistance values of the electrodes and muscles are merely illustrative example to explain the principles of the present invention. Other resistance values may also be used. With reference toFIG. 22A and as explained in detail regardingFIGS. 11C-11D, the initial current (when thearrangement513 is in the voltage mode) that runs through the muscle reaches apeak value521 during the pulse flank that may, for example, be about 25 mA that rapidly decreases to the workingcurrent level525 that may, for example, be about 3 mA when the internal resistance in the electrodes is about 100 Ohm, the muscle resistance is about 6500 Ohm and the pulse voltage is 20V. In this example, about 0.3V is lost in each electrode. The internal resistance in each electrode could increase to about 1000 Ohm or any value higher substantially than 1000 Ohm. When the resistance is 1000 Ohm, the current is 20V/8500 Ohm=2.35 mA which is the maximum current going through the muscle. Because the muscle is like a capacitor the maximum charging current is not more than 10 mA (20V/2000 Ohm=10 mA because the capacitance is between the electrodes through the muscle. The level of the current maximum after thepeak521 is dependent on the total resistance (i.e. the resistance of the electrodes plus muscle resistance). In the above example, the resistance is about 6500 Ohm in the muscle and 1000 Ohm in each electrode so that the maximum current is then 2.35 mA (20V/8500 Ohm=2.35 mA) as shown bycurve523 inFIG. 22A.

FIG. 22B illustrates the voltage across the electrode when the electrodes have an internal resistance of 100 Ohm each and how the voltage gradually increases to avoltage level527 such as 19.4V which is lower than thevoltage 20V. This is because the voltage drop in the electrodes is 0.3V in each electrode (3 mA×100 Ohm=0.3V) of thepulses494 of thestimulation signal512. The reduction of the current peak increases the voltage drop at the electrodes.FIG. 22C illustrates the muscle and electrodes with a resistance of 100 Ohm each when the voltage mode is used. If the peak current is 25 mA (charging the capacitance) and each

electrode

134,136 has an electrode resistance of 100 Ohm then 2.5V of the voltage is lost at each

electrode

134,136 during the peak top so the voltage is 15V between electrodes and at the muscle, as shown inFIG. 22B. When the current decreases during the pulse the voltage increases between electrodes and over themuscle502, as illustrated byFIG. 22B. At a current level of 3 mA, about 0.3V is lost at each

electrode

134,136 when the resistance of each electrode is 100 Ohm which explains why thevoltage527 across themuscle502 only reaches 19.4V inFIG. 22B. If the total resistance through themuscle502 is about 6500 Ohm and the

electrodes

134,136 each has a resistance of 1000 Ohm each then there is a total resistance of 8500 Ohm in the circuit. The resulting maximum current, when voltage thepulses494 is at 20V and the total resistance is 8500 Ohm, is 2.35 mA as shown bycurve523 inFIG. 22A and illustrated inFIG. 22D.FIG. 22D is identical toFIG. 22C except that the resistance of

electrodes

134,136 has increased from 100 Ohm to 1000 Ohm. Again, because the muscle is like a capacitor the charging current is maximum 10 mA when the electrodes have a resistance of 1000 Ohm each (20V pulse/electrode resistance 2000 Ohm=10 mA and this because there is capacitance between the electrodes through the muscle).FIGS. 22A and 22B thus illustrate the drawbacks of using the voltage mode because the current cannot be controlled as it can when thearrangement513 is in the current mode.

Another very important feature of the present invention is that the arrangement513 (shown inFIG. 10) may be included in each sub-control unit such assub-control unit122 shown inFIG. 23. This signals750,754 and759 come from the CPU of the sub-control unit instead of the CPU of the master unit. Preferably, the CPU of the sub-control units receive instructions from the CPU of the master unit about how the

signals

750,754 and759 should be adjusted or set. The inclusion of thearrangement513 at each sub-control unit makes it possible to run a first current at a first sub-control unit that is different from a second current at a second sub-control unit because thesignal759 at each sub-control unit sets the current limits as explained in detail above regardingFIG. 10. Additionally, the CPU of each sub-control unit can also set the pulse length via switch SW1, as explained in detail above.

It is possible to add a volt regulating circuit in the sub-control units so that the sub-control units may adjust (lower) the voltage of thepulse512 that is received from the master unit. For example, when the arrangement is in the voltage mode, the sub-control unit can set a maximum level of the pulse voltage going to

units

535a,535b,535cand535dthrough the switch SW1. When the arrangement is in the current mode the voltage is set to the maximum value and the current is set by the arrangement that in turn affects the voltage of the stimulation signal so that the current is constant, as explained in connection withFIG. 10. All the information about what the sub-control unit should do is received as instructions from the master unit that in turn receives input information from the therapist that sets the stimulation pattern for the patient from a PC stimulation software program that sends instructions to the master unit.

FIG. 23 shows a modifiedsub-control unit122′ that includes anarrangement513′ that is substantially similar to the arrangement513 (shownFIG. 10) so that theunit122′ can adjust (lower) the voltage, the pulse length and the current (when in the current mode). More particularly,stimulation pulse signal512 arrives from themaster unit266 from switch SW1 shown inFIG. 24. TheCPU531 receives thestimulation signal512 atpulse input782. TheCPU531 is electrically connected to the

output units

535a,535b,535c,535d. The details of the output units are described in connection withFIG. 16 and apply to the output units inFIG. 23 also. TheCPU531 may keep or lower the voltage of thestimulation pulse signal512 by sending a pulse voltage level control signal1110 to a pulsevoltage control circuit1112 so that the voltage of thestimulation pulse signal512 at pulse in1114 remains the same or is lowered at pulse out1116. For example, thecircuit1112 can lower the voltage of the stimulation signal from, for example, 60V to another voltage value such as 20V. Thecircuit1112 can also keep the voltage of thestimulation signal512 unchanged. As described in detail inFIG. 10, it is not important change the voltage when thearrangement513′ is in the current mode.

TheCPU531 may send apulse control signal754′ to switch the switch SW1 between an open position and a closed position in the same way assignal754 described in detail inFIG. 10 and it can also be switched to be on all the time because it is a pulse that comes from the master unit. In this way, theCPU531 can shorten thepulse length495 ofstimulation signal512 so thatstimulation signal512′ leaving the switch SW1 has ashorter pulse length498′. The switch SW1 can also keep the pulse length the same i.e. the same as the pulse length ofstimulation signal512 by activating the switch to be on all the time. The

output units

535a,535b,535c,535dreceives thestimulation signal512′ and can keep the pulse length the same or shorten the pulse length received from the CPU further by activating allow pulse-outfunctions794a.794b,794cand794d, respectively, as described inFIG. 16. TheCPU531 can switch thearrangement513′ between a current mode and voltage mode by sending acontrol signal750′ to switch SW2, as described inFIG. 10. TheCPU531 can set the current limit by sending thesignal759′ to thecomparator756′ and afeedback signal752′ is sent back toCPU531 to inform theCPU531 about the current level. All the principles that apply toarrangement513 also apply toarrangement513′ and are therefore not described here.

Theoutput units535a-dare electrically connected to electrodes134-148. The details are shown inFIG. 16 and all the details ofFIG. 16 also apply toFIG. 23 although some details have been omitted fromFIG. 23 for clarity. Theunit535a-dare electrically connected to feedback circuits1118a,1118b,1118cand1118dthat measure EMG signals i.e. the natural very small voltage signals from the muscles, as described inFIG. 9. Preferably, each feedback circuit includes a switch and amplifier to switch the amplifier in and out that measures the natural voltage signals from the muscles. The circuits1118a-dsend

feedback signals

1120a,1120b,1120cand1120dto theCPU531 so the CPU can determine whether to change the voltage, pulse length or current of thestimulation signal512′.

FIG. 24 shows asimplified switch arrangement513″ of the master unit that can be used when the sub-control units include thearrangement513′. In other words, the master unit can be simplified to merely send out stimulation pulses. The main function ofarrangement513″ is to create the pulses ofstimulation signal512 frompulse power511. For example, thearrangement513″ does not include the circuitry U1 or a switch SW2 to switch the arrangement between a current mode and a voltage mode. Thearrangement513″ is always in the voltage mode and createsstimulation pulses512 by opening and closing switch SW1, as described in connection withFIG. 10. Preferably, themaster unit266 still send out thepulsating stimulation signal512 to the sub-control units for safety reason. If each sub-control unit would generate the stimulation voltage such as 40V the risk increases that something could go wrong which is very uncomfortable to the user. It is safer to have the master unit generate the stimulation voltage because it has separate hardware that makes such the voltage does not exceed certain preset limits. The master unit also has hardware that controls the pulse length to make sure it does not exceed a preset limit. This provides better safety compared to generating the high voltage signal in each sub-control unit.

Preferably, the voltage ofsignal512 is higher than what is needed to stimulate the muscles because thecircuit1112 at each sub-control unit can lower the voltage to a desired level. In this way, it is possible to use a first voltage level at a first sub-control unit and a second voltage level at a second sub-control unit that is different from the first voltage level. However, the master unit sets the maximum pulse length and the maximum voltage in the stimulation signal and the local CPU at the sub-control unit can only keep the same values or lower the voltage or shorten the pulse length. Additionally, the CPU of the sub-control unit can set the current limit i.e. it can increase or decrease the current as desired as long as there is sufficient voltage in the stimulation signal from the master unit. Because each output unit has its own allow pulse out function, it is possible to use a first pulse length to the first pair of electrodes (i.e.electrodes134,136) and a second different pulse length to the second pair of electrodes (i.e.electrodes138,140) because the allow pulse out function can be set at different values for eachoutput unit535. If, for example, the pulse length of thestimulation pulse512 is 200 microseconds, the pulse length can first be shortened at switch SW1 to, for example, 180 microseconds and then further shortened to, for example, 175 microseconds by using the allow pulse-out794 function of the output unit, Each pulse in thestimulation signal512 is sent to all sub-control units so thatpulse 1 is used by

sub-control units

1 and 3 while the second pulse is used bysub-control unit 2 etc. This means thatsub-control unit 2 does not send outpulse 1 to the electrodes that the master unit selected by serial data communication to the sub-control unit.

The master unit sends data to all the sub-control unit and to each one when the sub-control units have a separate address. The sub-control units receive information about to which electrode or electrodes should receive the stimulation signal and in which order. For example,

sub-control units

1 and 3 may be instructed to simultaneously sendpulse 1 to electrodes andsub-control unit 2 may send outpulse 2 to its electrodes according tostimulation 1 of its list of stimulation pulses that are to be sent to the electrodes. This principle applies to all the sub-control units and all the sub-control units receive instructions about which pulse they should send out according to the list of stimulations that the master unit has sent them. Ifsub-control unit 1 uses

pulse

1 and 2 as the first stimulation pulse signal andsub-control unit 2 uses

pulse

3 and 4 to send out pulses whilesub-control unit 3 uses

pulse

5 and 6 to send out pulses and when there are only 3 sub-control unit in use then the 7 pulse is sent out bysub-control unit 1 again Each sub-control unit are connected with a plurality of electrodes so it sends out the stimulation pulses according to the instructions received from the master unit.

It is also possible for several sub-control units to simultaneously send out stimulation signals to the electrodes because all the sub-control unit receive the stimulation signals from the master unit. It is also possible for the master unit to vary the pulse length of each pulse in the stimulation signal so thatpulse 1 is, for example, 200 microseconds while the second pulse is, for example, 175 microseconds and the third pulse is, for example, 180 microseconds. It is also possible to change the voltage level for each pulse in the same way. This would primarily be used when certain nodes lack thearrangement513, the allow pulse-out794 function and the ability to locally control the pulse length.

It is also possible to utilize multi-programs in the body-suit that include a mild muscle contraction program and then use a moisturizing and/or conductive cream/gel to be applied locally on the skin where muscle contractions take place just before stimulation signals are sent to start the treatment of the muscles/nerves.

A suitable frequency range of the stimulation signal may be in a range of 1 Hz to 120 Hz that covers most excitatory and inhibitory intervention needs. The lower end of the frequency range would be useful for testing and palpated or automated intensity adjustments. It is also an important feature of the present invention to be able to use different frequencies in different channels for adapting to different requirements in individual lesion profiles.

It is also possible to stimulate skin afferents although the size and sensitivity ranges are very broad ranging from fast group II myelinated to very slow group IV unmyelinated and conduction speed from approx. 1 to 70 m/s wherein the speed is proportionally sensitive to the artificial stimuli.

As mentioned above, strong stimulation for inducing muscle contractions can be limited when using dry electrodes because most spinal cord injured patients also lose their ability to sweat (lesion effects also the autonomous neural system) and then the electrical contact resistance cannot adapt with delivered moisture. It is therefore particularly important that the present invention enables the control and adjustments of voltage, current and pulse length etc. to adjust the stimulation signals to the conditions of the skin and patient.

It has been realized that the stimulation of many locations in the body such as muscles and nerves by using the body suit of the present invention increases the release of opioid receptors so that multi-focal stimulation reduces pain in general and could be a method for reducing the need for patients to take pain killers such as opioid pills.

FIG. 25 is a schematic view of an alternative embodiment of thebody suit1200 of the present invention that haslarge electrodes1202.Body suit1200 is substantially similar to the body suits shown inFIGS. 4 and 18 and operate in the same way. Thebody suit1200 is not described in detail because all the features described in connection with the embodiments shown inFIGS. 4 and 18 also apply tobody suit1200. The only difference betweenbody suit1200 and the embodiments shown inFIGS. 4 and 18 is thatbody suit1200 has verylarge electrodes1202 that are connected to sub-control units1204. Theelectrodes1202 could be made so large that they cover substantially all the surfaces on thebody suit1200. Also, the number of sub-control units1204 is higher compared to thebody suit100 to enable more electrodes in the suit. Only a portion of the body suit is shown inFIG. 25 and thebody suit1200 could be made to cover the entire body as shown inFIG. 4.

It is to be understood that the present invention is not limited to be used in connection with the body suit shown inFIG. 4 and other figures. Thebody suit100 is merely an illustrative example. The sub-control units and the electrodes could be used in connection with any garment or piece of fabric. The garment could be separate pieces of fabric that contain the electrodes. It is even possible to place the electrodes directly on the skin of the patient without a garment or fabric holding the electrodes in place. In addition to the upper-body, the arms, pelvis and leg modules, the body suit can also be divided in other ways so that specific areas of the body are stimulated. For example, when the patient to be treated has a handicap that makes it difficult to use the body suit, smaller pieces of elastic or non-elastic materials, that contain electrodes, may be used so that the material pieces are placed on the parts of the patient's body that need stimulation. Another example is when the patient suffers from bed sores, the small pieces of garment or fabric containing the electrodes may be placed on the patient's body/skin so that the wound and its circumference can be stimulated. The small pieces of elastic fabric with electrodes are controlled by the master unit and each small piece is controlled by sub-control units that in turn control the electrodes in the same way as described above. The number of sub-controls units is determined by the number of electrodes in the small pieces. It is also possible to use full body sized garment pieces with the same technology so that patients/persons can lie on the large garment piece or so that a portion of the patient's body can lie on the garment to stimulate different muscles/nerves without the patient having to get into a body suit. The small pieces can be made to include an extra weight so that a good contact with the electrodes is obtained when the electrodes are placed on top of a muscle on the body.

In addition to using electrodes in a garment to read physiological signs, it is also possible to add sensors in the garment orbody suit100 to read accelerations, relative positions, angles and thereby movements of body parts of the person wearing thebody suit100. The present invention is not limited to the use of the body-suit or modules thereof. The body-suit is merely used as an illustrative example, Electrodes and other sensors may also be applied to a belt, band or other devices that are held towards the skin of the body of the user. Motion sensors, angle sensors, temperature sensors and acceleration sensors, and pressure sensors and sensors for reading ECG signals (Electrocardiogram—abbreviated as EKG or ECG) from the heart with electrodes placed on the body suit may be used to measure activities of the body parts of the person wearing thegarment100. Based on these readings, it is possible to decide how to stimulate muscles (either by facilitating contraction or by causing a contraction of certain muscles) and thereby influence/improve or alter the breathing, movement and relative position of the body or body-posture of the person wearing thegarment100. For example, the garment or body-suit100 or modules of the body suit such asright arm module102, anupper body module104, aleft arm module106, apelvis module108, aright leg module110 and aleft leg module112, as described inFIG. 4, could be used that include sensors to, for example, measure movements and positions of the various modules of thebody suit100 and to make sure the posture and movements of the person wearing the body-suit100 are correct. If the body posture is off, the master unit could be used to stimulate or activate muscles to improve the posture. Similarly, the body suit or modules of the body-suit (that includes motion and positioning sensors) could be used to measure whether the patient is sitting or standing in the same position too long. In this example, the master unit could send signals to stimulate certain muscles such as the hamstrings and butt muscles to increase blood flow and prevent sit-sores.

The body-suit100 or the modules102-112 could also include sensors to measure breathing, and to measure the ECG signals received from the heart and to measure vibration caused by snoring. The master unit could then send stimulation signals to stimulate muscles to facilitate breathing or send an alert signal to the user if the user stops breathing. It is also possible to send signals that create a nuisance to the user of the body-suit or modules to influence or encourage the user to sleep on the stomach or the side, as opposed to sleeping on the back to reduce snoring. The same body-suit or modules could be used to stimulate the genital nerves and activate muscles to improve incontinence or postpartum urinary incontinence and even to prevent or reduce sexual orgasm disorders. Thegarment100 may also be used to perform a real time gait analysis and adjust the stimulation of muscles to improve walking, running and breathing and also to measure improvements in real time. Stimulation socks (that include sensors) may be used to measure pressure areas under the foot plant to enable a more precise gait analysis.

By using different sensors and using electrodes as sensors placed in the garment/body-suit100 or

separate modules

102,104,106,108,110,112 of the body-suit (as shown and described inFIG. 4) such as jacket, sleeves, gloves, pants, underwear, leg garment parts, socks and head-gear that all include sensors, it is possible to analyze how different stimuli affect the body of the wearer of thegarment100 when the muscles of the user wearing the garment are stimulated. By analyzing the measured signals received from different sensors/electrodes and with the knowledge of which stimulations are being carried out, themaster unit266 can automatically adjust the stimulation so that an optimal effect is obtained when the stimulation is running on the body of the user wearing the garment or body-suit100 or modules of the body suit, as described inFIG. 4. By using the measured input from the sensors, it is possible to create regulatory loops in the software of themaster unit266 that automatically adjusts the stimulation by reading signal from sensors/electrodes over time for better results.

Preferably, the software is self-adjusting towards optimal stimulation to assist the user's body to achieve the desired movements of the body parts of the user. It is possible to run different programs in the master unit to accomplish different stimuli to resolve certain problems. It is also possible to run predetermined stimuli and automatically adjust stimuli for specific disorders. Sensors can be integrated into the garments or modules of the garments. It is also possible to use separate stimulation units that are not part of the garment and apply the stimulation units onto muscles that require stimulation.

By using sensors that are integrated into the garment or body-suit100 or modules of the garment, it is possible to sense or determine the position of the body of the person wearing thegarment100. Stimulation signals to muscles of the user can then be used to alter the body position or the stimulation signals may be used to indicate or alert the user about the need to alter or correct the body position. For example, it may be desirable to cause the person to change a position that can cause excessive wear and tear on the body. It is also possible to measure any change of the body position from an optimal position and when the current position deviates too much from the optimal position, the master unit can send stimulations to the muscle of the user to cause the user to change position to be closer to the optimal position.

It is also possible to simply to inform the user about need for changing his/her position. This can be used to prevent wear and tear injuries on the body. For example, a worker at a conveyor belt or a driver who drives for long periods of time may be standing or sitting in a wrong body position that should be corrected. If a worker/driver is wearing the garment, muscles can be stimulated so that the worker/driver returns to a good body posture. Also, the use of thegarment100 makes it possible to sense when a user is about to fall asleep by sensing changes in position of the body or other signals that indicate that the user is about to fall asleep. It is then possible to stimulate muscles of the user so that the user does not fall asleep.

By measuring movements of the body of a user wearing the garment and using different types of stimulation to control the movement of the body parts of the user it is possible improve the movements and to make them more optimal. The stimulation can be electrical stimulation pulses sent to the muscles of the user wherein the pulses have different frequencies and variable amplitude, current and pulse lengths. It is also possible to use vibrators or acoustic signals to inform the user that the position of the body or body part is not correct.

It is also possible to receive and measure electrical signals sent from the brain and the sensors can then sense and compare actual physical movements of body parts by using motion sensors, angle sensors, temperature sensors, acceleration sensors and ECG signal from the heart sensed from different body parts and compare those with the electrical signals received from the brain. More particularly, it is possible to determine the sweet-spot for relaxing an antagonist muscle and how to contract an agonist muscle safely. This could involve reading EEG signals from brain and the signals from measuring the breathing and measuring the heart ECG signal.

Electroencephalography (EEG) is a method of recording the spontaneous electrical activity of the cerebral cortex using electrodes. In other words, by using sensors on the head of the user that sense and receive signals from the head, it is possible to determine changes in the EEG signals from the head while the muscles are being relaxed or stimulated to approach optimal stimulation or stimulations. By slowly increasing the strength of the stimulation signals to one muscle or nerve at a time while registering the EEG signals, it is possible to determine changes of the EEG signals during the muscle stimulation or relaxation. When a change of the EEG signals occurs, it may be desirable to either stop or lower the level of the stimulation slightly in order not to continue changing the EEG signals. The stimulation level that causes the EEG signals to start changing may be treated as the optimal “sweet-spot” stimulation strength for that muscle/nerve that is being stimulated. It is then possible to stop the stimulations of the first muscle and start stimulating a second muscle/nerve in the same way until the sweet spot for the second muscle is also found. It is then possible to go through and stimulate selected muscles of the user in the same way and determine the stimulation strength that is desired for each muscle. This information can be used in a stimulation program that can be used to stimulate the selected muscles/nerves.

The optimal stimulations (sweet-spot) may, for example, relate to accomplishing an optimal contraction or relaxation of a muscle or as pain relief or regeneration/recuperation. It is also possible to create software that automatically searches for optimal stimulation strengths for selected muscles/nerves of a patient by measuring the EEG signals while at the same time stimulating the muscles so that the program can vary the stimulation strength for each muscle/nerve to find the sweet-spot for each muscle/nerve. It is also possible to create a program that reads signals from the heart ECG and stimulates to enhance the respiratory function. For example, the frequency of the ECG signal may be measured i.e. to measure how the heart rate (frequency) increases during inhaling and how the heart rate (frequency decreases during exhaling. For example, it is then possible to provide assistance to the user of the garment or body-suit by electrical stimulation to improve breathing by stimulating during inhalation and stop the stimulation during exhalation.

With reference toFIG. 26, thearm509 is shown.FIG. 26 is substantially similar toFIG. 9 and all information that applies toFIG. 9 also applies toFIG. 26. The main difference is thatFIG. 26 focuses on measuring the position and movement of thearm509. Theunderarm1300 of thearm509 is movable between a stretch outposition1302 and an uprightangular position1304 and indicated by thedouble arrow1306. The user preferably wears thearm module102, that includes many electrodes, over thearm509. Themodule102 includes an upper motion andposition sensor1308 that senses the position and whether the muscle/nerve502 moves and a lower motion andposition sensor1310 that senses the position and whether the muscle/nerve508 moves. Themodule102 also includes asensor1312 at anelbow1314 of themodule102 that senses the position and whether the arm is being or has been bent at theelbow1314. For example, the sensors make it possible to sense and measure how thearm509 including the underarm1300 have moved as a result of stimulation of the muscles/

nerves

502,508 on upper-arm1301 by sending signals to the

electrodes

134,136 and

electrodes

138,140, as described in detail inFIG. 9. In other words, the sensors show the resulting movements of the stimulation of the muscle/

nerves

502,508 and these results can then be compared to the movements that were intended when the electrodes were stimulated. As described earlier, the muscles can be stimulated to relax and by increasing the stimulation, the muscles can cause a change or movement of thearm509 and under-arm1300. Themaster unit266 may include an algorithm that can be used so that the master unit can learn by analyzing the actual movement compared which stimulation signals work best to accomplish an intended movement of thearm509 and theunderarm1300. It may also be possible to measure the amount of relaxation of a muscle by using the

sensors

1308,1310 and1312 by, for example, measuring the arm position or the surface tension at the muscle (pressure sensors) or whether the muscle is expanded or collapsed. The strength, frequency, length of the stimulation signal may be adjusted, as described in detail regardingFIG. 9. For example, if there is no movement of the arm after a first stimulation then a second stronger stimulation may be used to cause the arm or under-arm to move as intended. The arm may be very tense or locked in theangled position1304 and by relaxing the correct muscles (such asmuscle502 or muscle508) the arm relaxes so that the underarm1300 moves towardsposition1302. The strength and other variables of the stimulation signal can be adjusted based on the resulting relaxation or movements of the muscles in the arm. It may also be possible to receive and analyze EEG signals from the brain and continuously adjust the stimulation of the muscles based on the EEG signals received in order to minimize the changes of the EEG signals, as mentioned above. This information can then be saved in a database in order to develop standard stimulation signal criteria based on statistical data for various muscle relaxation and muscle movements.

FIG. 27 illustrates how the body posture of anupper body1319 of aperson1320 may change from anupright body posture1322 to an undesirable forward leaningbody posture1324, as indicated bydouble arrow1326. The length of thearrow1326 may represent arange1325 of acceptable body postures of pre-stored desirable positions. When theupper body1319 is outside thisrange1325, as set in the software, the body posture should be corrected until theupper body1319 is inside therange1325 as set in the software in the master unit or sub-control unit. One goal is to stimulate muscles of theperson1320 wearing thebody suit100 or a module (such as upper body module) of the garment or body-suit so that his body posture moves from posture1324 (that is slightly outside the range1325) to be within therange1325 towards the mostdesirable posture1322. For example, muscles in thestomach area1328 and theback area1330 may be stimulated to accomplish the movement towards theupright position1322. A position and/or

motion sensor

1332,1334 may be placed on thesuit100 to detect and measure movements of the person. It may also be possible to first detect the incorrect body posture i.e. theupper body1319 is outside theacceptable range1325, and merely notify theperson1320 that the body posture should be corrected without electrical stimulation such as by using sound or vibration. It is also possible to use a lower limit for starting the stimulation and an upper limit for stopping the stimulation. These limits may be set in the software on the master unit or sub-control unit. It is also possible to add a time to the software that allows a certain amount of time outside the restriction area before the stimulation starts to correct or assist the person wearing the body-suit orgarment100.

FIG. 28 illustrate how the body posture of aperson1340 may change from anupright sitting position1342 to a forward leaningposition1344, as indicated bydouble arrow1346. For example, the forward leaningposition1344 may indicate that the person is about to fall asleep while driving acar1348. The electronics and master unit described above can either stimulate muscles to move theperson1340 from theposition1344 to theupright position1342 or the person may be alerted by vibration or a sound. Theperson1340 may have

sensors

1350,1352 placed on the clothing orbody suit100 or one of the body suite modules to measure the position and movement of the upper body of theperson1340. The sensors can thus be used to first determine that the person is in an undesirable position. The sensors can also be used to determine the position of the person as feedback after muscles have been stimulated or after the person has been alerted about the incorrect position. It may also be possible to first detect the incorrect body posture and merely notifying theperson1340 that the body posture should be corrected without electrical stimulating such as by using sound or vibration.

In operation, a garment or body-suit100 worn by the patient is provided. Thegarment100 has a first sub-control unit122 (seeFIG. 4) electrically connected to afirst electrode134 and asecond electrode136 placed at a first muscle orfirst nerve502 of the patient and athird electrode138 and afourth electrode140 placed at a second muscle orsecond nerve508. The firstsub-control unit122 is preferably electrically connected to themaster unit266. Thegarment100 has

sensors

1308,1310,1312,1314 attached to the garment and electrically connected to the firstsub-control unit122. The sensors measure a position or movement of the patient wearing thegarment100. Themaster unit266 or the firstsub-control unit122 receives information about the position or movement and compare the position or movement to anacceptable interval1325 of pre-stored desirable positions or movements. The interval may be stored in themaster unit266 or the firstsub-control unit122 and represent body positions or body postures that are within an acceptable range or unacceptable range. For example, when the measured position or movement is outside the interval (or unacceptable range) then themaster unit266 or the firstsub-control unit122 sends astimulation signal512 to thefirst muscle502 to cause or facilitate a contraction of thefirst muscle502 inFIG. 25. When the measured position or movement is within the interval the master unit or the first sub-control unit sends no stimulation signals because the body position or body posture of the patient or user is acceptable and there is no need for correction.

In an alternative embodiment, the method further comprises the step of the sensor measuring an acceleration of a body part such as under-arm1300 associated with thefirst muscle134.

In an yet another embodiment, the method further comprises the step of thesensor1314 measuring an angle between an upper-arm1301 and of the body part (under-arm)1300 associated with thefirst muscle502.

In another embodiment, the method further comprises the step of themaster unit266 sending stimulation signals to a set of muscles to move a body part of the patient from the position to be within the interval of pre-stored desirable positions.

In yet another embodiment, the method further comprises the step of the sensor measuring a body posture of the patient.

In an alternative embodiment, the method further comprises the step of the sensor measuring a new position after the first muscle or first nerve has been stimulated by the stimulation signal. Themaster unit266 may then send a second stimulation signal to the first muscle or first nerve depending upon the new position i.e. depending on how much the first stimulation signal affected the position. The second subsequent stimulation signal may be stronger than the first stimulation signal such as by using a higher voltage/current, higher frequency or longer pulse length. The specific characteristics of the second subsequent stimulation signal is determined by themaster unit266 that is based on a feedback signal related to the resulting movement from the first stimulation signal. Themaster unit266 may also decide to stimulate other muscles by sending stimulation signals to additional electrodes.

In another embodiment, the method further comprises the step of the master unit sending a second subsequent stimulation signal to cause an increase of blood flow in the first muscle.

In yet another embodiment, the method further comprises the step of the sensor measuring breathing of the patient and stimulation helps the body to breathe correctly.

In another embodiment, the method further comprises the step of sensor measuring and analyzing movements of body parts of the patient in real time.

With reference toFIG. 29, it is possible to use a device that reads brain waves and stimulates the brain with electrodes that may be located behind the ears, forehead or any other area on the head of the patient/user to trigger the release of chemicals at the brain level to improve the well-being of the patient. Preferably, the device should function with or without being coupled to thegarment100.

With the electrodes that read or receive signals from the brain it is also possible to stimulate the brain with the same electrodes but not at the same time as signals are being received from the brain. It is possible to stimulate for during a first time period and read/receive signals or brain waves during a subsequent second time period that is separate from the first time period. The electrodes may be placed in different places on the head and neck that are controlled by an electronic module that can both read and stimulate the brain. In order to make a good contact between the skin on the head and the electrodes, areas where there is a lot of hair should be avoided. Suitable places to place the electrodes are therefore on the forehead, behind the ears or on the neck. Ifmaster unit266 is used for this, it is possible to run stimulations of the brain and read signals from the brain without wearing the garment or body-suit100. It is possible to use multiple electrodes on the head to achieve optimal stimulation and measurement of signals from the brain. Preferably, the stimulation of the brain and receipt of brain signals should not be done simultaneously due to the risk of undesirable interference. It is to be understood that the electronics unit does not have to be placed on the forehead as shown inFIG. 28. The placement of this device on the forehead is merely an example and it can be placed in other places as long as it is not too far away from the head to be able to receive from and send signals to the brain. Preferably, small EEG signals may be measured from the head so the conductors from the electrodes to the electronics unit should not be too far away from each other. For example, the electronics unit can also be placed behind the ears. Electroencephalography (EEG) refer to signals of electrical activity of the cerebral cortex using electrodes usually placed on the scalp.

FIG. 29 is substantially similar toFIG. 18. Everything that applies toFIG. 18 also applies toFIG. 29. Only the differences are here described.

Electrodes

831,833 are electrically connected to thesub-control unit814 via

wires

835,837, respectively. The

electrodes

831,833 are preferably position immediately behind or below the

ears

839,841 where there is no hair. The

electrodes

831,833 may be used to stimulate thebrain843 disposed inside thehead830 with stimulation signals such asstimulation signal512, described earlier. Thesignal512 may be pulse, sine, triangular or saw-tooth shaped signals. Preferably, thesignal512 is sine-shaped wherein the frequency and the amplitude (voltage or ampere) may be changed, as illustrated inFIG. 10. It may be possible to connectmaster unit266 toconnector802 so that the stimulation of thebrain843 can be done without having to use the body-suite100. Preferably, the patient is using the body-suit100. It is also possible to switch the functions of the

electrodes

831,833 and

electrodes

824,828 so that

electrodes

831,833 are used for receiving brain signals while

electrodes

824,828 are used for sending stimulations signals to the brain. It is also possible to alternate the functions so the electrodes provide stimulations signals certain time periods while receiving brain signals other time periods. As mentioned above, preferably the sending of stimulation signals and receipt of brain signals should not be done simultaneously to reduce the risk of interferences. It is also possible to measure the brain signals using all the connected electrodes on the head and combine the electrodes to find and measure optimal signals from the brain. In other words, all the electrodes may be used for either receiving brain signal or sending stimulation signals to the brain or both.

It is possible to adjust the stimulation to whether the user or patient is inhaling or exhaling. During exhalation, it is preferable that the stimulation is either reduced or stopped in order not to interfere with the lowering of the beating rhythm of the heart. During inhalation, it is preferable to increase the stimulation or that the stimulation is started if not stimulation is taking place. It is desirable that the activity of the breathing muscles or the use stretch sensors/mechanical receptors in a garment such as body-suit100 sends out a signal to trigger the master unit to send signals to trigger the stimulation.

In operation, the method is for treating a patient. Afirst electrode824, asecond electrode828, athird electrode831 and afourth electrode833 are placed on ahead830 of the patient. The first, second, third and fourth electrodes are electrically connected to amaster unit266 orsub-control unit814. In other words, themaster unit266 may be connected directly to the electrodes but it is preferably connected to the electrodes viasub-control unit814. All the features that apply tosub-control unit122 described above all apply tosub-control unit814.

Themaster unit266 orsub-control unit814 generates afirst stimulation signal512, during a first time period, to the first and

second electrodes

824,828 to stimulate thebrain843 inside thehead830 with thefirst stimulation signal512. The third and

fourth electrodes

831,833 receive afirst brain signal847 from thebrain843, during a second time period, and forwards thefirst brain signal847 to themaster unit266 orsub-control unit814. Preferably, the first time period is different and distinct from the second time period so there is no overlap between the first and second time periods. Themaster unit266 orsub-control unit814 then analyzes thefirst brain signal847 and adapting a second stimulation signal based on information in thefirst brain signal847. Themaster unit266 orsub-control unit814 generates a second stimulation signal, during a third time period, to the third and

fourth electrodes

831,833. Preferably, the third time period is subsequent to the second time period so that there is no overlap between the second and third time periods. The first and

second electrodes

824,828 then receive a second brain signal849 from thebrain843. The first and

second electrodes

824,828 send thesecond brain signal849 to themaster unit266 orsub-control unit814. Themaster unit266 orsub-control unit814 then analyzes thesecond brain signal849 and adapts a third stimulation signal based on information in thesecond brain signal849.

In an alternative embodiment, agarment100 worn by the patient is provided. Thegarment100 having

electrodes

134,136 attached to amuscle502 of the patient. The

electrodes

134,136 are electrically connected to themaster unit266 orsub-control unit122.

In another embodiment, themaster unit266 orsub-control unit814 sends astimulation signal512 to themuscle502 to stimulate themuscle502. Thestimulation signal512 has a strength and a frequency based on information in thefirst brain signal847 received from thebrain843.

In yet another embodiment, themaster unit266 orsub-control unit814 compares the measured first and second brain signals847,849 with brain wave patterns, stored in a database, and the brain wave patterns being associated with movements of body parts.

In another embodiment, themaster unit266 orsub-control unit814 determines, based on the measured first and second brain signals847,849, which

muscles

502,508 to stimulate to cause movement of body parts.

In yet another embodiment, the first and

second electrodes

831,833 are placed behind

ears

839,841 of the patient.

With reference toFIG. 30, the “sweet-spot” for relaxing an antagonist muscle can be determined while determining how to safely contract an agonist muscle. This involves reading and interpreting signals sent from the affected muscles and to study signals received from the brain. The breathing and heart pulse may also be analyzed.

More particularly, it is possible to measure electrical pulses or electroencephalography signals (EEG) from the brain or electrical pulses or electrocardiography signals (ECG) from the heart. When an EEG signal is received and there is a change of this signal compared to earlier EEG signals that have been measures by the electrodes mounted on the head of the patient, this may indicate that there is activity in a muscle or nerve. The distance between the peaks on the ECG signals indicate how fast the heart is beating. The longer the distance between the peaks of the signal the slower the heart is beating. Consequently, the shorter the distance between the peaks the faster the heart is beating.

When the EEG signals from the brain are measured and sent to themaster unit266, it is important to detect differences in these signals. The same thing applies to ECG signals from the heart. The change in either the EEG signal or ECG signal is a trigger to the master unit to stimulate a certain muscle or nerve depending upon the content of the signals received by the master unit. For example, the EEG signal may first be measured and evaluated by the master unit via the electrodes that are mounted on the head of the patient/user of thebody suit100. The master unit is able to interpret that different EEG signals received and translate them to which muscles should be stimulated depending upon the content of the EEG signals received. If, for example, the EEG signal received indicates that the user would like to lift an arm then the master unit will send a stimulation signal to the correct muscle or muscle group to accomplish the lifting of the arm that the user is thinking based on the content of the EEG signals. A change in the EEG signal is thus translated or converted by the master unit into a muscle stimulation. Another change in the EEG signal may trigger the master unit to stimulated another muscle or set of muscle to accomplish something else such as moving the left leg.

The same principle applies to ECG signals from the heart. For example, if the heart start beating at a higher frequency i.e. the pulse increases. This pulse increase may be an indication that the user has become upset, this may be as trigger to the master unit to reduce any stimulation signal to a muscle that is moving in order to reduce the rate of the heart pulse. If the master unit receives an ECG signal from the heart that indicates that the heart rate is too low then the master unit may increase the stimulation of muscles such as breathing muscles to increase the load on the heart and thus the heart rate. If the user of the body suit has a certain blood pressure that is decreased this may be a trigger to the master unit to increase the stimulation of muscles to increase the heart rate and thus the blood pressure. If the blood pressure is too high then it is possible for the master unit to reduce or stop any muscle stimulation to reduce the load on the heart and thus the blood pressure.

As described in relation toFIGS. 1-3, it is possible to stimulate an agonist muscle in order to relax an antagonist muscle. This concept is also described inFIG. 9. All the principles that apply toFIGS. 1-3 and 9 also apply to the embodiment shown inFIG. 30 and described therein. Signals from the antagonist muscle are measured to determine whether the muscle is sufficiently relaxed as a result of the mild stimulation (without causing the agonist muscle to contract) of the agonist muscle. Instead of measuring signals from the antagonist muscle it is possible to instead measure signals from the brain as a result of the stimulation of the agonist muscle. In other words, during the stimulation of the agonist muscle, any change of the brain signal from the cortex as a result of this stimulation is measured i.e. the patient feels, for example, vibrations in the skin at the muscle. The amount stimulation of the agonist muscle that is need to cause a change of the brain signal is called the “sweet-spot” and is a threshold value that is lower than the motoric threshold value that causes the muscle to contract/twitch. There is another sweet-spot that determines at which level, i.e. the motoric threshold value, that causes the muscle to contract.

It is particularly important to be able to read and determine when there is a change of the brain signal when the patient is unable to communicate this such as when the patient is severely handicapped or has a brain damage. It is to be understood that the stimulation of the agonist muscle could either be just sufficient to cause the change of the brain signal without causing the agonist muscle to contract. The stimulation signal could also be strong enough to cause the agonist muscle to contract to move a body part associated with the agonist muscle. This means it may sometimes be necessary to stimulate the agonist muscle until it contracts or twitches to cause the monitored brain signal to change. The signals from the brain are received by electrodes mounted to the skull enclosing the brain of the person treated. Both the change of the brain signal, as sensed by the electrodes mounted on the head of the person, or a change of the signal received back from the antagonist muscle may be treated as feedback to the stimulation of the agonist muscle. All the various signals are either received by a sub-control unit or the master unit, as described in detail above. It should be understood that it is possible to measure both feedback signals from the antagonist muscle and/or feedback or changes of brain signals received via the electrodes to the master unit.

By being able to read and determine when the brain senses that the agonist muscle is being stimulated, it is possible to automatically calibrate the master unit to send out a more precise stimulation signal without having to ask the person to be treated when the person feels the stimulation of the agonist muscle. In this way, the master unit may include a ramping program that successively increases the stimulation signal to the agonist muscle until a change of the relevant brain signal is received by the master unit so the master unit can determine how strong the stimulation signal should be to relax the antagonist muscle without being required to ask the patient/person for feedback.

There are thus two sweet-spot or threshold values that the master unit can read from the brain. The first sweet spot value is the threshold of the stimulation signal at which there is a change of the brain signal to indicate that the person senses that the agonist muscle is stimulated. The other sweet-spot value is the motoric threshold value at which the brain signal indicates that the agonist muscle starts to move.

FIG. 30 is substantially similar toFIGS. 9, 18, 26 and 28 and all information that have already been described in connection withFIGS. 9, 18, 26 and 28 also apply toFIG. 29 so the common information is not described here again. In addition,FIG. 29 shows asub-control unit122 that is electrically connected to the

electrodes

134,136,138 and140 via

wires

134a,136a,138aand140a, as described in connection withFIG. 4 above. Theunit122 is also electrically connected toconnector802 via

wires

1400,1402 and to another sub-control unit or themaster unit266 via

wires

1404,1406.

In operation, themaster unit266 sends a stimulation signal such asstimulation signal512 to stimulate theagonist muscle502 via

electrodes

134,136, as described in detail regardingFIGS. 1-3 and 9. The stimulation ofmuscle502 relaxes theantagonist muscle508. This relaxation may either be detected by themaster unit266 receiving a feedback signal from themuscle508 or by a change of an EEG or brain signal847 received from thebrain800 via the

electrodes

824,826,831,833 andsub-control unit814. In other words, thebrain signal847 is forwarded to thesub-control unit814 that, in turn, forwards thesignal847 to themaster unit266 via other sub-control units such assub-control unit802. The trigger ofbrain signal847 may be movement or vibrations on the skin at anarea1408 at themuscle508 or an area1420 at themuscle502. This change or vibration in thearea1408 may also be sensed by

sensors

1308 or1310 that is sent to themaster unit266. The change inarea1408 orbrain signal847 may also be used by themaster unit266 to send another stronger stimulation signal to muscle502 to cause themuscle502 to contract to move a body part such aslower arm1300 from a first stretched-out position to a second bent position or vice-versa. Themaster unit266 thus translates thesignal847 to which muscle should be activated i.e. based on what the person wearing thebody suit100 thinks or wants to do.

More particularly, the method of the present invention is for treating a patient. Agarment100 worn by the patient is provided. Thegarment100 has a firstsub-control unit122 electrically connected to afirst electrode134 and asecond electrode136 placed at a first muscle orfirst nerve502 of the patient. The firstsub-control unit122 is electrically connected to amaster unit266. A

fifth electrode

824,828,831,833 is placed at a head of the patient. The fifth electrode measures abrain voltage signal847 from a

brain

800,843 of the patient. The

fifth electrode

824,828,831,833 sends the measuredbrain voltage847 signal to a second sub-control unit (814) or themaster unit266. A

sixth electrode

172,174,176,178,202,204,206,208,210,212,214,216 is placed adjacent to a heart of the patient. The sixth electrode measures a heart signal from the heart of the patient. The secondsub-control unit814 or themaster unit266 analyzes the measuredbrain voltage signal847 and/or heart signal to determine which muscle to stimulate. Themaster unit266 adapts afirst stimulation signal512 to the firstsub-control unit122 based on the measuredbrain voltage signal847 or heart signal. The firstsub-control unit122 stimulates the first muscle orfirst nerve502 with the first stimulation signal by sending the first stimulation signal to thefirst electrode134 placed at the first muscle orfirst nerve502.

In an alternative embodiment, the method further comprises the step of stimulating the first muscle orfirst nerve502 to relax asecond muscle508.

In another embodiment, the method further comprises the step of stimulating thefirst muscle502 to move a body part associated with thefirst muscle502.

In yet another embodiment, the method further comprises themaster unit266 measuring a change in thebrain signal847 or heart signal to determine which muscle to stimulate.

In an alternative embodiment, the method further comprises the master unit (266) detecting a first threshold value of thebrain signal847 or heart signal that causes thestimulation signal512 to stimulate thefirst muscle502 without contracting the first muscle and detecting a second threshold value that causes the movement of thefirst muscle502 as a result of thestimulation signal512, the second threshold value being greater than the first threshold value.

In another embodiment, the method further comprises the step of themaster unit266 retrieving a feedback signal from the second muscle or thebrain signal847 to determine which muscle to stimulate.

While the present invention has been described in accordance with preferred compositions and embodiments, it is to be understood that certain substitutions and alterations may be made thereto without departing from the spirit and scope of the following claims.

Claims

We claim:

1. A method for treating a patient, comprising:

providing a garment worn by the patient, the garment having a first sub-control unit electrically connected to a first electrode and a second electrode placed at a first muscle or first nerve of the patient, the first sub-control unit being electrically connected to a master unit;

providing a fifth electrode placed at a head of the patient, the fifth electrode measuring a brain voltage signal from a brain of the patient;

the fifth electrode sending the measured brain voltage signal to a second sub-control unit or the master unit;

providing a sixth electrode placed adjacent to a heart of the patient, the sixth electrode measuring a heart signal from the heart of the patient;

the second sub-control unit or the master unit analyzing the measured brain voltage signal and/or heart signal to determine which muscle to stimulate; and

the master unit adapting a first stimulation signal) to the first sub-control unit based on the measured brain voltage signal or heart signal, the first sub-control unit stimulating the first muscle or first nerve with the first stimulation signal by sending the first stimulation signal to the first electrode placed at the first muscle or first nerve.

2. The method ofclaim 1 wherein the method further comprises the step of stimulating the first muscle or first nerve to relax a second muscle.

3. The method ofclaim 1 wherein the method further comprises the step of stimulating the first muscle to move a body part associated with the first muscle.

4. The method ofclaim 1 wherein the method further comprises the master unit measuring a change in the brain signal or heart signal to determine which muscle to stimulate.

5. The method ofclaim 1 wherein the method further comprises the master unit detecting a first threshold value of the brain signal or heart signal that causes the stimulation signal to stimulate the first muscle without contracting the first muscle and detecting a second threshold value that causes the movement of the first muscle as a result of the stimulation signal, the second threshold value being greater than the first threshold value.

6. The method ofclaim 1 wherein the method further comprises the step of the master unit retrieving a feedback signal from the second muscle or the brain signal to determine which muscle to stimulate.